Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer

NCT00002931 | Completed Phase 2 Results

• 5 other identifiers: 96126P30CA033572CHNMC-96126NCI-G97-1136CDR0000065365
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bone marrow transplantation or peripheral stem cell transplantation works in treating patients with relapsed germ cell cancer.

Conditions

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

Keywords

recurrent malignant testicular germ cell tumor; testicular seminoma; testicular embryonal carcinoma; testicular choriocarcinoma; testicular yolk sac tumor; testicular embryonal carcinoma and teratoma; testicular embryonal carcinoma and teratoma with seminoma; testicular embryonal carcinoma and yolk sac tumor; testicular embryonal carcinoma and yolk sac tumor with seminoma; testicular embryonal carcinoma and seminoma; testicular yolk sac tumor and teratoma; testicular yolk sac tumor and teratoma with seminoma; testicular choriocarcinoma and yolk sac tumor; testicular choriocarcinoma and embryonal carcinoma; testicular choriocarcinoma and teratoma; testicular choriocarcinoma and seminoma; recurrent ovarian germ cell tumor; recurrent extragonadal non-seminomatous germ cell tumor; recurrent extragonadal seminoma; recurrent extragonadal germ cell tumor; adult teratoma; testicular immature teratoma; testicular mature teratoma; ovarian immature teratoma; ovarian mature teratoma; ovarian monodermal and highly specialized teratoma; stage III malignant testicular germ cell tumor; stage IV ovarian germ cell tumor; stage IV extragonadal non-seminomatous germ cell tumor; stage IV extragonadal seminoma; adult central nervous system germ cell tumor

Outcome Measures

Primary Outcomes (2)

• Progression-free Survival

  Estimated using the product-limit method of Kaplan and Meier. Progression is defined as an increase o any radiologically measureable tumor by greater than 25% or a greater than 10% increase of elevated tumor markers.

  Until disease progression, up to 5 years.

• Toxic Effects

  Number of Participants with Grade 3 and 4 Adverse Events Related to Protocol-based Therapy

  From date of randomization until death of any cause, assessed up to 12 weeks

Secondary Outcomes (1)

• Overall Survival

  Until death from any cause, up to 5 years.

Study Arms (1)

HD Chemo and Auto Stem Cells

EXPERIMENTAL

Biological: filgrastim; Drug: carboplatin; Drug: etoposide; Drug: ifosfamide; Drug: paclitaxel; Procedure: autologous bone marrow transplantation; Procedure: bone marrow ablation with stem cell support

Interventions

filgrastim BIOLOGICAL

5 ug/kg bid beginning 4 days prior to and continuing through stem cell collection.

HD Chemo and Auto Stem Cells

carboplatin DRUG

AUC=7, daily X 3

HD Chemo and Auto Stem Cells

etoposide DRUG

20 mg/kg by 2 hours infusion daily X 3

HD Chemo and Auto Stem Cells

ifosfamide DRUG

3 gm/m2 IV over 30 minutes X 3 days

HD Chemo and Auto Stem Cells

paclitaxel DRUG

425 mg/m2 as 24 hour continuous infusion

HD Chemo and Auto Stem Cells

autologous bone marrow transplantation PROCEDURE

Given in two divided infusions on day -2 and day 0

HD Chemo and Auto Stem Cells

bone marrow ablation with stem cell support PROCEDURE

Two cycles of high dose chemotherapy followed by stem cell reinfusion

HD Chemo and Auto Stem Cells

Eligibility Criteria

• Age: 16 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Evaluable germ cell cancer (measurable by radiographic study and/or serum tumor marker elevation) and not curable by standard salvage therapy OR viable cancer on resection of post-chemotherapy residual masses in either intermediate or high risk category * Bidimensionally measurable disease with measurements performed within 21 days of study entry * Tumor marker (alpha-fetoprotein, lactate dehydrogenase, beta-human chorionic gonadotropin) studies performed within 7 days prior to study entry PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * Karnofsky 70-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 120,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin no greater than 1.6 mg/dL * SGOT and SGPT no greater than 2 times upper limit of normal (ULN) * No active hepatitis or cirrhosis Renal: * Creatinine clearance at least 70 mL/min Cardiovascular: * Ejection fraction (MUGA or echocardiogram) normal * No EKG evidence of active cardiac disease (arrhythmias, ischemia) which would contraindicate etoposide and paclitaxel study treatment Pulmonary: * PaO\_2 at least 70 mm Hg * FEV\_1 at least 2 L or 75% * No history of bleomycin associated or serious lung disease Neurologic: * No steroid or glucocorticoid treatment for patients with CNS metastatic disease; at least 1 month with stable post-radiotherapy neurological status and seizure free; if prior seizures, at least 1 month with therapeutic anticonvulsant levels prior to study * Prior peripheral neuropathy requires consultation with principal investigator Other: * No significant active medical illness precluding study or survival * Not HIV positive * No prior malignancy within past 5 years except for adequately treated basal cell or squamous cell skin cancer * No prior hematologic malignancies PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior bone marrow or stem cell rescue with high-dose chemotherapy Chemotherapy: * Prior chemotherapy allowed, excluding high-dose therapy with bone marrow or stem cell rescue * No prior paclitaxel Endocrine therapy: * Not specified Radiotherapy: * No concurrent radiotherapy during study Surgery: * Recovered from prior surgery

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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Ovarian Neoplasms; Teratoma; Testicular Germ Cell Tumor; Testicular Neoplasms; Seminoma; Endodermal Sinus Tumor; Carcinoma, Embryonal

Interventions

Filgrastim; Carboplatin; Etoposide; Ifosfamide; Paclitaxel

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; Germinoma; Mesonephroma

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; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Results Point of Contact

• Title: Paul Frankel, Ph.D.
• Organization: City of Hope

pfrankel@coh.org

626-359-8111

Study Officials

• Sumanta Pal, MD

  City of Hope Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: February 1, 1997
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 23, 2017
• Results First Posted: January 4, 2017

Record last verified: 2017-01

Locations

US (1)