Paclitaxel, Ifosfamide, and Carboplatin Followed By Autologous Stem Cell Transplant in Treating Patients With Germ Cell Tumors That Did Not Respond to Cisplatin

NCT00423852 | Completed Phase 1 Results

• 2 other identifiers: 06-077MSKCC-06077
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. An autologous peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to be given so that more tumor cells are killed. PURPOSE: This phase I/II trial is studying the side effects and best dose of ifosfamide when given together with paclitaxel and carboplatin followed by an autologous stem cell transplant and to see how well they work in treating patients with germ cell tumors that did not respond to cisplatin.

Conditions

Brain and Central Nervous System Tumors; Extragonadal Germ Cell Tumor; Ovarian Cancer; Teratoma; Testicular Germ Cell Tumor

Keywords

recurrent ovarian germ cell tumor; stage III ovarian germ cell tumor; stage IV ovarian germ cell tumor; recurrent malignant testicular germ cell tumor; adult central nervous system germ cell tumor; stage III malignant testicular germ cell tumor; stage II malignant testicular germ cell tumor; recurrent extragonadal non-seminomatous germ cell tumor; recurrent extragonadal seminoma; stage III extragonadal non-seminomatous germ cell tumor; stage III extragonadal seminoma; stage IV extragonadal non-seminomatous germ cell tumor; stage IV extragonadal seminoma; recurrent extragonadal germ cell tumor; adult teratoma; testicular immature teratoma; testicular mature teratoma

Outcome Measures

Primary Outcomes (2)

• Response

  Response assessed at the completion of therapy (after four to five cycles of chemotherapy and after surgery if necessary) Complete Response (CR): A complete response is defined as one of the following: * Complete disappearance of all clinical and radiographic and biochemical (normal AFP and HCG) evidence of disease for a minimum of 4 weeks (CR to chemotherapy). * Complete disappearance of all biochemical evidence of disease with resection of residual radiographic masses that prove to be negative for residual GCT; this includes both mature teratoma and necrotic debris (CR to chemotherapy) for a minimum of 4 weeks. * Complete disappearance of all biochemical evidence of disease with complete surgical excision of all residual radiographic masses that, if pathologically positive for residual malignant GCT, show margins to microscopically free of disease (CR to chemotherapy + surgery). Patients must be free of disease for a minimum of 4 weeks.

  2 year

• Maximum Tolerated Dose of Ifosfamide

  4 years

Study Arms (1)

chemotherapy with Stem Cell Support

EXPERIMENTAL

This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.

Biological: filgrastim; Drug: carboplatin; Drug: ifosfamide; Drug: paclitaxel; Procedure: autologous hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation

Interventions

filgrastim BIOLOGICAL

chemotherapy with Stem Cell Support

carboplatin DRUG

chemotherapy with Stem Cell Support

ifosfamide DRUG

chemotherapy with Stem Cell Support

paclitaxel DRUG

chemotherapy with Stem Cell Support

autologous hematopoietic stem cell transplantation PROCEDURE

chemotherapy with Stem Cell Support

peripheral blood stem cell transplantation PROCEDURE

chemotherapy with Stem Cell Support

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed germ cell tumor (GCT) * Primary CNS GCT allowed * Unidimensionally measurable disease OR elevated serum tumor markers (alpha-fetoprotein and/or human chorionic gonadotropin) * Advanced disease * Disease resistant to a cisplatin-based chemotherapy regimen (i.e., failed to achieve a durable complete response to cisplatin) * Known residual disease after post-chemotherapy surgery allowed PATIENT CHARACTERISTICS: * Platelet count ≥ 100,000/mm\^3 * WBC ≥ 3,000/mm\^3 * Creatinine clearance \> 50 mL/min (unless due to tumor obstructing the ureters) * AST and ALT \< 2 times upper limit of normal (ULN) * Bilirubin \< 1.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infection * Negative serology for HIV type I and II, human T-lymphotropic virus type I and II, hepatitis B or C virus, syphilis, and cytomegalovirus * Hepatitis C negative serology by RIBA or PCR * Adequate medical condition for general anesthesia PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from recent surgery * At least 3 weeks since prior chemotherapy * No prior high-dose therapy with autologous bone marrow transplantation * No other concurrent chemotherapy * No other concurrent treatment (e.g., surgery or radiotherapy)

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Ovarian Neoplasms; Teratoma; Testicular Germ Cell Tumor; Testicular Neoplasms

Interventions

Filgrastim; Carboplatin; Ifosfamide; Paclitaxel; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Genital Neoplasms, Male; Genital Diseases, Male; Male Urogenital Diseases; Testicular Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; 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; Organic Chemicals; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Darren Feldman, Assistant Attending
• Organization: Memorial Sloan Kettering Cancer Center

Feldmand@mskcc.org

+1646-422-4491

Study Officials

• Darren Feldman, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2007
• First Posted: January 18, 2007
• Study Start: August 1, 2006
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: May 18, 2016
• Results First Posted: May 18, 2016

Record last verified: 2016-04

Locations

US (1)