Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients with Relapsed or Refractory Germ Cell Tumors

NCT02375204 | Active Not Recruiting Phase 3 DMC

• 3 other identifiers: A031102U10CA180821NCI-2014-01696
• Study Type: interventional
• Target: 420
• Locations: 12 countries
• Sites: 125

Brief Summary

This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumors.

Conditions

Germ Cell Tumor; Teratoma; Choriocarcinoma; Germinoma; Mixed Germ Cell Tumor; Yolk Sac Tumor; Childhood Teratoma; Malignant Germ Cell Neoplasm; Extragonadal Seminoma; Non-seminomatous Germ Cell Tumor; Seminoma

Outcome Measures

Primary Outcomes (1)

• overall survival

  Up to 36 months post-treatment

Secondary Outcomes (5)

• progression free survival

  Up to 36 months post-treatment

• proportion of patients achieving either a complete response (CR) or partial response

  Up to 3 months post-registration

• treatment related mortality

  Up to 30 days post-treatment

• number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Up to 3 months post-registration

• Validation of International Prognostic Factor Study Group stratification system (eg, primary site, prior response, progression free interval)

  Up to 3 years post-registration

Study Arms (2)

Arm A: TIP

OTHER

Patients will receive treatment for 4 cycles administered every 21 days. Cycles 1-4 (1 cycle = 21 days) * paclitaxel 250 mg/m\^2 IV over 24 hours on Day 1 including premedication as defined in the protocol (eg, dexamethasone, diphenhydramine and H2 blocker) * ifosfamide 1500 mg/m\^2 IV daily on Days 2-5 with mesna protection as defined in the protocol * cisplatin 25 mg/m\^2 IV daily on Days 2-5 * pegylated G-CSF 6 mg subcutaneous on Day 6 or 7 or G-CSF as defined in the protocol on Days 6-18 Patients may commence with each Arm A cycle provided they meet the criteria as defined in the protocol.

Drug: paclitaxel; Drug: ifosfamide; Drug: cisplatin; Drug: pegylated G-CSF; Drug: G-CSF

Arm B: TI-CE

OTHER

Patients will receive treatment for a total of 5 cycles. Cycles 1-2 (1 cycle = 14 days) * paclitaxel 200 mg/m\^2 IV over 3 hours on Day 1 including premedication as defined in the protocol (eg, dexamethasone, diphenhydramine and H2 blocker) * ifosfamide 2000 mg/m\^2 IV daily on Days 1-3 with mesna protection as defined in the protocol * G-CSF 10 µg/kg subcutaneously on Days 3-15 (cycle 1) and Days 3-14 (cycle 2) or pegylated G-CSF 6 mg subcutaneous on Day 4 or 6 (cycle 1) and Day 4 or 5 (cycle 2) * leukapheresis every 14 days, if there is an inadequate number of CD34+ cells/kg collected in cycle 1 Cycles 3-5 (1 cycle = 21 days) * carboplatin daily on Days 1-3 * etoposide 400 mg/m\^2 daily on Days 1-3 * stem cell reinfusion on day 5 * pegylated G-CSF 6 mg subcutaneously or G-CSF at approximately 5 µg/kg daily on Days 5-15 Patients may commence with each Arm B cycle provided they meet the criteria as defined in the protocol.

Drug: paclitaxel; Drug: ifosfamide; Drug: pegylated G-CSF; Drug: G-CSF; Drug: carboplatin; Drug: etoposide phosphate; Procedure: stem cell reinfusion

Interventions

paclitaxel DRUG

IV

Also known as: Taxol

Arm A: TIP; Arm B: TI-CE

ifosfamide DRUG

IV

Also known as: Ifex®, IFOS

Arm A: TIP; Arm B: TI-CE

cisplatin DRUG

IV

Also known as: CDDP

Arm A: TIP

pegylated G-CSF DRUG

IV

Arm A: TIP; Arm B: TI-CE

G-CSF DRUG

IV

Arm A: TIP; Arm B: TI-CE

carboplatin DRUG

IV

Also known as: Paraplatin®, CBDCA

Arm B: TI-CE

etoposide phosphate DRUG

IV

Also known as: VePesid®, Toposar®, VP16

Arm B: TI-CE

stem cell reinfusion PROCEDURE

surgical procedure

Arm B: TI-CE

Eligibility Criteria

• Age: 14 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

1. Documentation of Disease * Histologic Documentation: Confirmation of GCT histology (both seminoma and nonseminoma) on pathologic review at the center of enrollment. * Tumor may have originated in any primary site. NOTE: In rare circumstances, patients will be allowed to enroll even if a pathologic diagnosis may not have been established. * This would require a clinical situation consistent with the diagnosis of GCT (testicular, peritoneal, retroperitoneal or mediastinal mass, elevated tumor marker levels {HCG ≥ 500; AFP ≥ 500} and typical pattern of metastases) 2. Evidence of Disease * Must have evidence of progressive or recurrent GCT (measurable or non-measurable) following one line of cisplatin-based chemotherapy, defined as meeting at least one of the following criteria: * Tumor biopsy of new or growing or unresectable lesions demonstrating viable non-teratomatous GCT (enrollment on this study for adjuvant treatment after macroscopically complete resection of viable GCT is not allowed). In the event of an incomplete gross resection where viable GCT is found, patients will be considered eligible for the study. * Consecutive elevated serum tumor markers (HCG or AFP) that are increasing. Increase of an elevated LDH alone does not constitute progressive disease. * Development of new or enlarging lesions in the setting of persistently elevated HCG or AFP, even if the HCG and AFP are not continuing to increase. 3. Prior Treatment * Must have received 3-6 cycles of cisplatin-based chemotherapy as part of first-line (initial) chemotherapy. * Prior POMBACE, CBOP-BEP, or GAMEC are allowed. * Note: For patients requiring immediate treatment, 1 cycle of conventional-dose salvage chemotherapy is allowed. Therefore, these patients may have received 7 prior cycles of chemotherapy. 6 cycles as part of first-line chemotherapy and 1 cycle of salvage conventional chemotherapy. * No more than one prior line of chemotherapy for GCT (other than the 1 cycle of salvage chemotherapy as defined in the protocol) * Definition of one line of chemotherapy: One line of therapy can in some cases consist of 2 different cisplatin-based treatment combinations, provided there is no disease progression between these two regimens. * Prior treatment with carboplatin as adjuvant therapy is allowed, provided patients meet other eligibility criteria (e.g., the patient has also received 3-4 cycles of cisplatin-based chemotherapy). * Prior treatment with 1-2 cycles of BEP or EP as adjuvant chemotherapy for early stage GCT is allowed, provided the patient also received 3-4 cycles of BEP or EP again at relapse. Patients treated with 3-4 cycles of VIP at relapse following 1-2 cycles of BEP/EP are not eligible as this would be considered more than 1 line of prior therapy. * No prior treatment with high-dose chemotherapy (defined as treatment utilizing stem cell rescue) * No prior treatment with TIP with the exception when given as a bridge to treatment on protocol for patients with rapidly progressive disease who cannot wait to complete the eligibility screening process. Only one cycle is allowed. * No concurrent treatment with other cytotoxic drugs or targeted therapies. * No radiation therapy (other than to the brain) within 14 days of day 1 of protocol chemotherapy except radiation to brain metastases, which must be completed 7 days prior to start of chemotherapy. * No previous chemotherapy within 17 days prior to enrollment. A minimum of three weeks after the last day of the start of the previous chemotherapy regimen before the first day of chemotherapy on study protocol. * Must have adequate recovery from prior surgery (eg, healed scar, resumption of diet) 4. Age ≥ 14 years (≥ 18 years in Germany) 5. ECOG Performance Status 0 to 2 6. Male gender 7. Required Initial Laboratory Values: * Absolute Neutrophil Count (ANC) ≥ 1,500/mm\^3 * Platelet Count ≥ 100,000/mm\^3 * Calculated creatinine clearance ≥ 50 mL/min * Bilirubin ≤ 2.0 x upper limits of normal (ULN) * AST/ALT ≤ 2.5 x upper limits of normal (ULN) 8. No concurrent malignancy other than non-melanoma skin cancer, superficial noninvasive (pTa or pTis) TCC of the bladder, contralateral GCT, or intratubular germ cell neoplasia. Patients with a prior malignancy, but at least 2 years since any evidence of disease are allowed. 9. Negative Serology (antibody test) for the following infectious diseases: * Human Immunodeficiency Virus (HIV) type 1 and 2 * Human T-cell Leukemia Virus (HTLV) type 1 and 2 (mandatory in US but optional in Canada and Europe) * Hepatitis B surface antigen * Hepatitis C antibody 10. No late relapse with completely surgically resectable disease. Patients with late relapses (defined as relapse ≥ 2 years from the date of completion of the last chemotherapy regimen) whose disease is completely surgically resectable are not eligible. Patients with late relapses who have unresectable disease are eligible. 11. No large (≥ 2 cm) hemorrhagic or symptomatic brain metastases until local treatment has been administered (radiation therapy or surgery). Treatment may begin ≥ 7 days after completion of local treatment. Patients with small (\< 2 cm) and asymptomatic brain metastases are allowed and may be treated with radiation therapy and/or surgery concurrently with Arm A or cycles 1 and 2 of Arm B if deemed medically indicated. Radiation therapy should not be given concurrently with high-dose carboplatin or etoposide. 12. No secondary somatic malignancy arising from teratoma (e.g., teratoma with malignant transformation) when it is actively part of the disease recurrence or progression.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator
• Movember Foundation: collaborator
• Institute of Cancer Research (ICR), United Kingdom: collaborator
• Cancer Research UK: collaborator
• UNICANCER: collaborator
• Irish Group CTI: collaborator

Study Sites (125)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

Location

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States

Location

UCSF Medical Center-Mission Bay

San Francisco, California, 94158, United States

Location

Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

University of Florida Health Science Center - Gainesville

Gainesville, Florida, 32610, United States

Location

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207, United States

Location

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

Location

Miami Cancer Institute

Miami, Florida, 33176, United States

Location

Arnold Palmer Hospital for Children

Orlando, Florida, 32806, United States

Location

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, 33607, United States

Location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas - Wichita

Wichita, Kansas, 67214, United States

Location

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, 49503, United States

Location

University of Michigan Health - West

Wyoming, Michigan, 49519, United States

Location

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Summerlin Hospital Medical Center

Las Vegas, Nevada, 89144, United States

Location

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Saint Joseph's Regional Medical Center

Paterson, New Jersey, 07503, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

East White Plains, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Prisma Health Cancer Institute - Easley

Easley, South Carolina, 29640, United States

Location

Saint Francis Hospital

Greenville, South Carolina, 29601, United States

Location

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States

Location

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Saint Francis Cancer Center

Greenville, South Carolina, 29607, United States

Location

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States

Location

Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States

Location

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States

Location

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

The Children's Hospital at TriStar Centennial

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

El Paso Children's Hospital

El Paso, Texas, 79905, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701, United States

Location

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Marshfield Clinic-Minocqua Center

Minocqua, Wisconsin, 54548, United States

Location

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868, United States

Location

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482, United States

Location

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476, United States

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Institut Jules Bordet

Anderlecht, 1070, Belgium

Location

University Hospital Saint Luc

Brussels, 1200, Belgium

Location

Rigshospitalet University Hospital

Copenhagen, 2100, Denmark

Location

Centre Leon Berard

Lyon, 69373, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

Hopital Tenon/Assistance Publique - Hopitaux de Paris

Paris, 75970, France

Location

CHRU Strasbourg - Hospital Civil

Strasbourg, 67091, France

Location

Center Claudius Regaud

Toulouse, 31052, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

Technical University Dresden

Dresden, Saxony, 01307, Germany

Location

University of Berlin Charite Campus Benjamin Franklin

Berlin, 12203, Germany

Location

University of Dusseldorf

Düsseldorf, 40225, Germany

Location

University of Essen

Essen, 45122, Germany

Location

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

UniversitaetsKlinikum Heidelberg

Heidelberg, 69120, Germany

Location

GK-Mittelrhein Saint Martin's

Koblenz, 56068, Germany

Location

Philipps University Marburg

Marburg, 35033, Germany

Location

Rotkreuzklinikum Munchen

Munich, 80634, Germany

Location

Klinikum Nurnberg Nord

Nuremberg, 90419, Germany

Location

University Hospital Ulm

Ulm, 89081, Germany

Location

Saint James Hospital

Dublin, 8, Ireland

Location

Ospedale di Circolo di Busto Arsizio

Busto Arsizio, 21052, Italy

Location

Istituto Scientifico Romagnolo

Meldola, 47014, Italy

Location

Istituto Nazionale Tumori

Milan, 20133, Italy

Location

San Matteo Hospital

Pavia, 27100, Italy

Location

The Netherlands Cancer Institute

Amsterdam, 1066 CX, Netherlands

Location

University Medical Center Groningen

Groningen, 9700 GZ, Netherlands

Location

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

Hospital De La Santa Creu I Sant Pau

Barcelona, 08025, Spain

Location

Duran i Reynals Hospital-Catalan Institute of Oncology

Barcelona, 08908, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital General Universitario Morales Meseguer

Murcia, 30008, Spain

Location

Inselspital

Bern, 3010, Switzerland

Location

Hopitaux Universitaires de Geneve

Geneva, 1211, Switzerland

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Weston Park Hospital

Sheffield, England, S10 2SJ, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Saint James's University Hospital

West Yorkshire, England, LS9 7TF, United Kingdom

Location

Beatson Oncology Center

Glasgow, Scotland, G12 0YN, United Kingdom

Location

Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom

Location

The Royal Marsden NHS Foundation Trust - Sutton

Surrey, SM2 5PT, United Kingdom

Location

Related Publications (2)

• Gleeson JP, Knezevic A, Bromberg M, Patil S, Sheinfeld J, Carver BS, Bains M, Jones DR, Bajorin DF, Bosl GJ, McHugh DJ, Funt SA, Motzer RJ, Feldman DR. Paclitaxel, Ifosfamide, and Cisplatin as Initial Salvage Chemotherapy for Germ Cell Tumors: Long-Term Follow-Up and Outcomes for Favorable- and Unfavorable-Risk Disease. J Clin Oncol. 2024 Sep 10;42(26):3130-3139. doi: 10.1200/JCO.23.02542. Epub 2024 Jul 19.

  PMID: 39028926 DERIVED

• Tan YY, Al-Bubseeree B, Irvine D, MacDonald G, McQuaker G, Parker A, Waterston A, White J. High-Dose Chemotherapy in Relapsed or Refractory Metastatic Germ-Cell Cancer: The Scotland Experience. Clin Genitourin Cancer. 2019 Apr;17(2):125-131. doi: 10.1016/j.clgc.2018.11.013. Epub 2018 Nov 17.

  PMID: 30563754 DERIVED

MeSH Terms

Conditions

Neoplasms, Germ Cell and Embryonal; Teratoma; Choriocarcinoma; Germinoma; Endodermal Sinus Tumor; Nonseminomatous germ cell tumor; Seminoma

Interventions

Paclitaxel; Ifosfamide; Cisplatin; Granulocyte Colony-Stimulating Factor; Carboplatin; etoposide phosphate; Etoposide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Trophoblastic Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Pregnancy Complications, Neoplastic; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mesonephroma

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Coordination Complexes; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glucosides; Glycosides

Study Officials

• Darren Feldman, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: March 2, 2015
• Study Start: August 6, 2015
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2031
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

NL (3); US (77); BE (2); AU (4); DE (11); CH (3); ES (4); GB (8); IE (1); DK (1); IT (4); FR (7)