Overview

Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors

Status:
Completed
Trial end date:
2001-11-01
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 bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of melphalan and thiotepa plus bone marrow or peripheral stem cell transplantation in treating patients who have recurrent or refractory solid tumors.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fred Hutchinson Cancer Research Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Cyclophosphamide
Melphalan
Paclitaxel
Thiotepa
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed solid tumor Metastatic disease Recurrent
or refractory Pleural effusions allowed, if controlled Brain metastases allowed, if
symptoms controlled and negative MRI

PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3 No uncontrolled bleeding Hepatic: Bilirubin no greater
than 2.0 mg/dL SGOT and/or SGPT less than 3 times normal Renal: Creatinine no greater than
1.5 mg/dL Cardiovascular: Normal EKG Ejection fraction at least 45% Patients with abnormal
EKG, history of myocardial infarction, unstable angina, congestive heart failure, or prior
cumulative anthracycline dose of at least 250 mg/m2, must have a left ventricular ejection
fraction performed No congestive heart failure or uncontrolled hypertension Pulmonary: DLCO
greater than 60% No pneumonia No asthma, even if controlled Neurologic: No dementia or
altered mental status Other: No active infection (e.g., peritonitis, wound abscess) HIV
negative No prior cyclophosphamide induced hemorrhagic cystitis No serious concurrent
systemic disease (e.g., diabetes mellitus, hypothyroidism) No other active malignancies Not
pregnant Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No
other concurrent chemotherapy Endocrine therapy: Concurrent hormonal therapy allowed
Radiotherapy: No concurrent radiotherapy Surgery: At least 2 weeks since prior surgery and
recovered