Carboplatin, Etoposide, Cyclophosphamide, and Autologous Bone Marrow Transplantation in Patients With Relapsed or Refractory Cancer
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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 autologous bone marrow transplantation may help the body kill more tumor cells.
PURPOSE: Phase II trial to study the effects of high doses of carboplatin, etoposide, and cyclophosphamide followed by autologous bone marrow transplantation in patients with relapsed or refractory germ cell cancer and other chemotherapy-sensitive solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Extragonadal Germ Cell Tumor Ovarian Cancer Testicular Germ Cell Tumor Unspecified Adult Solid Tumor, Protocol Specific |
Drug: carboplatin Drug: cyclophosphamide Drug: etoposide Procedure: autologous bone marrow transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Bone Marrow Transplantation for Relapsed and Refractory Germ Cell Cancer: A Phase II Pilot Study |
- To investigate the response rate High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Transplantation [ Time Frame: 45 days ] [ Designated as safety issue: No ]
- evaluate toxicity of High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Transplantation [ Time Frame: 45 days ]
| Enrollment: | 11 |
| Study Start Date: | February 1993 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | October 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Investigate the response rate, duration of response, survival, time to marrow reconstitution, and toxicity of two successive cycles of high dose carboplatin, etoposide, and cyclophosphamide chemotherapy and ABMT in patients with relapsed and refractory germ cell cancer or other chemotherapy-sensitive solid tumors.
- Further define the pretransplant characteristics of patients and their disease that might influence the outcome of this therapy.
OUTLINE: Patients receive carboplatin and etoposide for 5 days and cyclophosphamide for 2 days prior to ABMT.
At day 60 following ABMT, if the patient has a complete response (CR) or partial response (PR) and nonhematologic toxicity is no greater than grade 2, a second ABMT course is given when hematologic parameters and other criteria are acceptable. If there is no CR or PR and/or nonhematologic toxicity exceeds grade 2, a second ABMT is not given.
After ABMT patients are followed until disease progression or death.
PROJECTED ACCRUAL: Ten patients will be accrued for this pilot study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed, measurable germ cell cancer relapsed or refractory after frontline therapy with cisplatin and etoposide-containing chemotherapy
- Other chemotherapy-sensitive solid tumors eligible (as of 06/11/97)
- Possibility of residual mass representing benign teratoma must be excluded
- Elevated serum tumor markers only are acceptable if possibilities of false-positive serum tumor markers or sanctuary disease have been excluded
- Also eligible after two to four cycles of conventional dose salvage chemotherapy, regardless of response
- No CNS or bone marrow involvement
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Greater than 2 months
Hematopoietic:
- Platelet count at least 100,000/mm3
- Neutrophil count at least 1,500/mm3
Hepatic:
- Bilirubin, alkaline phosphatase, SGOT, and SGPT less than 3 times upper limit of normal, unless due to disease
Renal:
- Creatinine less than 1.5 times upper limit of normal
- Creatinine clearance at least 60 ml/min
Cardiovascular:
- Ventricular ejection fraction at least 45%
- No uncontrolled or severe cardiovascular disease including recent myocardial infarction, congestive heart failure, angina, life-threatening arrhythmia, or hypertension
Pulmonary:
- DLCO and spirometry greater than 50% of predicted
Other:
- Not HIV positive
- No active peptic ulcer
- No uncontrolled diabetes mellitus
- No active infection
- No previous or concomitant malignancy other than curatively treated basal or squamous cell carcinoma of the skin
- Not HBsAG positive
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior high-dose carboplatin, etoposide, or cyclophosphamide
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Contacts and Locations| United States, North Carolina | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| Study Chair: | David D. Hurd, MD | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Comprehensive Cancer Center of Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT00002943 History of Changes |
| Other Study ID Numbers: | CDR0000065392, CCCWFU-95193, NCI-G97-1146 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Comprehensive Cancer Center of Wake Forest University:
|
stage III malignant testicular germ cell tumor recurrent malignant testicular germ cell tumor unspecified adult solid tumor, protocol specific stage III ovarian germ cell tumor |
stage IV ovarian germ cell tumor recurrent ovarian germ cell tumor extragonadal germ cell tumor |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Neoplasms, Germ Cell and Embryonal Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Neoplasms by Histologic Type Cyclophosphamide Etoposide phosphate |
Etoposide Carboplatin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 16, 2013