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Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: June 30, 2009   History of Changes
Sponsors and Collaborators: Beckman Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002931
  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 II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Tandem High-Dose Chemotherapy With Autologous Stem Cell Rescue for Poor-Prognosis Germ Cell Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Antitumor activity [ Designated as safety issue: No ]
  • Toxic effects [ 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)
Detailed Description:

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
Beckman Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: City of Hope Comprehensive Cancer Center ( George Somlo )
Study ID Numbers: CDR0000065365, CHNMC-96126, NCI-G97-1136
Study First Received: November 1, 1999
Last Updated: June 30, 2009
ClinicalTrials.gov Identifier: NCT00002931     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Gonadal Disorders
Seminoma
Urogenital Neoplasms
Ovarian Diseases
Central Nervous System Neoplasms
Etoposide phosphate
Genital Diseases, Female
Neoplasms, Germ Cell and Embryonal
Ovarian Cancer
Alkylating Agents
Etoposide
Nervous System Neoplasms
Endocrine Gland Neoplasms
Extragonadal Germ Cell Tumor
Ovarian Neoplasms
Testicular Cancer
Malignant Germ Cell Tumor
Choriocarcinoma
Genital Neoplasms, Female
Endocrine System Diseases
Antimitotic Agents
Carboplatin
Testicular Neoplasms
Recurrence
Carcinoma
Ifosfamide
Paclitaxel
Tubulin Modulators
Antineoplastic Agents, Alkylating
Nonseminomatous Germ Cell Tumor

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Antineoplastic Agents
Urogenital Neoplasms
Ovarian Diseases
Central Nervous System Neoplasms
Genital Diseases, Female
Neoplasms by Site
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Alkylating Agents
Nervous System Neoplasms
Endocrine Gland Neoplasms
Ovarian Neoplasms
Neoplasms by Histologic Type
Mitosis Modulators
Nervous System Diseases
Genital Neoplasms, Female
Endocrine System Diseases
Antimitotic Agents
Carboplatin
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Ifosfamide
Paclitaxel
Tubulin Modulators
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Teratoma

ClinicalTrials.gov processed this record on September 02, 2009