Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
City of Hope Medical Center
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00002931
First received: November 1, 1999
Last updated: November 21, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Extragonadal Germ Cell Tumor Ovarian Cancer Teratoma Testicular Germ Cell Tumor |
Biological: filgrastim Drug: carboplatin Drug: etoposide Drug: ifosfamide Drug: paclitaxel Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Tandem High-Dose Chemotherapy With Autologous Stem Cell Rescue for Poor-Prognosis Germ Cell Cancer |
Resource links provided by NLM:
Drug Information available for:
Ifosfamide
Paclitaxel
Etoposide
Carboplatin
Etoposide phosphate
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
U.S. FDA Resources
Further study details as provided by City of Hope Medical Center:
Primary Outcome Measures:
- Antitumor activity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Toxic effects [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 12 |
| Study Start Date: | February 1997 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Biological: filgrastim
5 ug/kg bid beginning 4 days prior to and continuing through stem cell collection.
Drug: carboplatin
AUC=7, daily X 3
Drug: etoposide
20 mg/kg by 2 hours infusion daily X 3
Drug: ifosfamide
3 gm/m2 IV over 30 minutes X 3 days
Drug: paclitaxel
425 mg/m2 as 24 hour continuous infusion
Procedure: autologous bone marrow transplantation
Given in two divided infusions on day -2 and day 0
Procedure: bone marrow ablation with stem cell support
Two cycles of high dose chemotherapy followed by stem cell reinfusion
OBJECTIVES:
- Estimate the antitumor activity of 2 courses of paclitaxel and carboplatin regimens with autologous stem cell rescue in patients with relapsed germ cell cancer.
- Evaluate the toxic effects of paclitaxel, carboplatin and etoposide (VP-16) with stem cell support followed by paclitaxel, carboplatin and ifosfamide with stem cell support in these patients.
OUTLINE: Patients receive filgrastim (G-CSF) SC or IV 4 days prior to peripheral blood stem cells (PBSC) apheresis. Autologous bone marrow harvest is performed when adequate stem cells cannot be collected.
Patients then receive course 1 of high-dose chemotherapy beginning on day -7 with paclitaxel IV over 24 hours. On days -6 to -4, patients receive etoposide IV over 2 hours and carboplatin (CBDCA) IV over 30 minutes 3 times daily. Following a 2 or 3 week recovery, a second course of chemotherapy begins on day -7, consisting of paclitaxel IV over 24 hours, then CBDCA and ifosfamide on days -6 to -4.
Reinfusion of PBSC and marrow begins on day -2 in both course 1 and 2. In addition, G-CSF IV is given twice a day until 3 consecutive postnadir days of granulocytes of at least 1000/mm^3 are maintained. On day 0, stem cells with or without bone marrow product are again administered.
Surgery may be performed after course 2 if indicated.
PROJECTED ACCRUAL: The expected accrual rate is 12 patients per year over 2 years.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002931
Locations
| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
Sponsors and Collaborators
City of Hope Medical Center
Investigators
| Study Chair: | Sumanta Pal, MD | City of Hope Medical Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT00002931 History of Changes |
| Other Study ID Numbers: | 96126, P30CA033572, CHNMC-96126, NCI-G97-1136, CDR0000065365 |
| Study First Received: | November 1, 1999 |
| Last Updated: | November 21, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by City of Hope Medical Center:
|
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 |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Ovarian Neoplasms Teratoma Central Nervous System Neoplasms Neoplasms, Germ Cell and Embryonal Neoplasms by Site Neoplasms Nervous System Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases |
Gonadal Disorders Neoplasms by Histologic Type Etoposide Paclitaxel Isophosphamide mustard Ifosfamide Carboplatin Lenograstim Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013