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

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Comprehensive Cancer Center of Wake Forest University; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Cyclophosphamide; Etoposide; Etoposide phosphate

Criteria

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