High-Dose Chemotherapy and Stem Cell Transplant in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to First-Line Therapy

NCT01172912 | Unknown Phase 2

• 4 other identifiers: ITA-MIL-INT-38-10CDR0000682204EUDRACT-2010-021898-36EU-21054
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. An autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. PURPOSE: This phase II trial is studying the side effects of giving high-dose chemotherapy together with stem cell transplant and to see how well it works in treating patients with metastatic germ cell tumors that have not responded to first-line therapy.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Efficacy

• Toxicity

• Biological correlates of outcome

Interventions

filgrastim BIOLOGICAL

pegfilgrastim BIOLOGICAL

carboplatin DRUG

cisplatin DRUG

dexamethasone DRUG

etoposide DRUG

ifosfamide DRUG

high-dose chemotherapy with autologous stem cell rescue OTHER

laboratory biomarker analysis OTHER

autologous hematopoietic stem cell transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed germ cell tumor (GCT) based on pathologic review at INT Milan * Metastatic disease * Relapsed or refractory disease * Prior chemotherapy treatment for GCT without a pathologic diagnosis due to unequivocal clinical evidence of GCT and an urgent need to start therapy (elevated alpha-fetoprotein \[AFP\] or human chorionic gonadotropin \[HCG\] with pattern of metastases consistent with GCT and high tumor burden) allowed * Unequivocal progression of measurable disease, consisting of abnormalities on 2-dimensional imaging or raised tumor markers, following 1 line of cisplatin-based chemotherapy as documented by either of the following: * Tumor biopsy of new, growing, or unresectable lesions demonstrating viable non-teratomatous GCT (enrollment on this study for adjuvant treatment after resection of viable GCT not allowed) * Increasing or abnormally elevated serum tumor markers (HCG or AFP) (increasing lactate dehydrogenase \[LDH\] alone does not constitute progressive disease) * Received ≥ 3 and ≤ 6, cisplatin-based chemotherapy courses as part of first-line (initial) chemotherapy and ≤ 6 cisplatin-based chemotherapy courses * Brain metastases allowed * May be treated with radiotherapy and/or surgery concurrently with cisplatin, ifosfamide, and etoposide regimen * Radiotherapy should not be given concurrently with mobilization phase/leukapheresis and high-dose carboplatin and etoposide PATIENT CHARACTERISTICS: * WBC ≥ 2,000/µL * ANC ≥ 1,500/µL * Platelet count ≥ 100,000/µL * Creatinine clearance ≥ 50 cc/min (unless renal dysfunction is due to tumor obstructing the ureters, in which case eligibility will be determined by the principal investigator) * AST/ALT \< 2 times upper limit of normal (ULN) (\< 5 times ULN if due to hepatic metastases) * Total bilirubin \< 1.5 times ULN * Ejection fraction ≥ 50% by echocardiogram * Negative serology for the following infectious diseases: * HIV type 1 and 2 * Hepatitis B surface antigen (active carriers) * Hepatitis C * Cytomegalovirus (serum Ag p65 ± PCR confirmation at principal investigator discretion) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior surgery * At least 3 weeks since prior chemotherapy * No prior high-dose chemotherapy with peripheral blood stem cell rescue * No more than 1 prior chemotherapy regimen for metastatic disease

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

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione Istituto Nazionale dei Tumori

Milan, 20133, Italy

RECRUITING

MeSH Terms

Conditions

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

Interventions

Filgrastim; pegfilgrastim; Carboplatin; Cisplatin; Dexamethasone; Etoposide; Ifosfamide; Drug Therapy; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Endocrine Gland Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

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; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Glucosides; Glycosides; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Transplantation; Surgical Procedures, Operative

Study Officials

• Alessandro M. Gianni, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 29, 2010
• First Posted: July 30, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2012
• Last Updated: August 12, 2013

Record last verified: 2011-08

Locations

IT (1)