Carboplatin, Etoposide, Cyclophosphamide, and Autologous Bone Marrow Transplantation in Patients With Relapsed or Refractory Cancer

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00002943

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

173.9

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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 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 or Disease	Intervention/Treatment	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

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Feb 1, 1993

Actual Primary Completion Date :

Oct 1, 2003

Actual Study Completion Date :

Aug 1, 2007

Outcome Measures

Primary Outcome Measures

To investigate the response rate High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Transplantation [45 days]

Secondary Outcome Measures

evaluate toxicity of High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Transplantation [45 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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