High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors

• Status: Completed
• Trial end date: 2003-05-01
• 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 peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of high-dose thiotepa plus peripheral stem cell transplantation in treating patients with refractory solid tumors.

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

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Thiotepa

Criteria

DISEASE CHARACTERISTICS:

• Malignant solid tumors

• Must have failed conventional treatment or for whom conventional therapy is not available

• Measurable disease by MRI or CT scan

• Intraocular retinoblastomas may be measured by direct visualization

• Germ cell tumors may be measured by tumor markers

• No known bone marrow involvement

PATIENT CHARACTERISTICS:

Age:

• Any age

Performance status:

• Lansky 60-100% for patients 16 and under

• Karnofsky 60-100% for patients over 16

Life expectancy:

• At least 8 weeks

Hematopoietic:

• Absolute neutrophil count at least 1,000/mm^3

• Platelet count at least 75,000/mm^3

• If parameters not met, must have adequate stem cell yield

Hepatic:

• Bilirubin no greater than 1.5 times the upper limit of normal (ULN)

• SGOT and SGPT no greater than 2.5 times the ULN (unless liver involvement by tumor)

Renal:

• Creatinine within normal limits OR

• Creatinine clearance at least 70 mL/min

Cardiovascular:

• Fractional shortening greater than 28% on echocardiogram OR

• Ejection fraction at least 55% on RNCA prior to first cycle of thiotepa

Pulmonary:

• DLCO greater than 55% of predicted (only required if there is clinical evidence of pulmonary dysfunction)

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Prior bone marrow or peripheral blood stem cell rescue allowed

Chemotherapy:

• At least 4 weeks since prior chemotherapy if absolute neutrophil count is less than 1,000/mm^3 or platelet count is less than 75,000/mm^3, and recovered (i.e. adequate stem cells collected to predict hematopoietic recovery)

• No concurrent chemotherapy except for dexamethasone for antiedema effects

Endocrine therapy:

• No concurrent use of corticosteroids used solely as antiemetics

Radiotherapy:

• At least 4 weeks since radiotherapy if absolute neutrophil count is less than 1,000/mm^3 or platelet count is less than 75,000/mm^3, and recovered (i.e. adequate stem cells collected to predict hematopoietic recovery)

• No concurrent radiotherapy

Surgery:

• Not specified