Carboplatin, Etoposide, Cyclophosphamide, and Autologous Bone Marrow Transplantation in Patients With Relapsed or Refractory Cancer
Status: | Completed |
---|---|
Conditions: | Ovarian Cancer, Cancer, Cancer, Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 120 |
Updated: | 8/12/2018 |
Start Date: | February 1993 |
End Date: | August 2007 |
High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Bone Marrow Transplantation for Relapsed and Refractory Germ Cell Cancer: A Phase II Pilot Study
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.
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.
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.
- 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.
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
We found this trial at
1
site
Medical Center Boulevard
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
336-716-2255
Comprehensive Cancer Center of Wake Forest University Our newly expanded Comprehensive Cancer Center is the...
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