Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors

• Status: Terminated
• Trial end date: 2003-08-01
• 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 peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of high-dose chemotherapy.

PURPOSE: Phase I trial to study the effectiveness of amifostine in protecting from the side effects of peripheral stem cell transplantation in treating patients who have high-risk or relapsed solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Treatments: Amifostine; Busulfan; Lenograstim; Melphalan; Sargramostim; Thiotepa

Criteria

Inclusion Criteria:

• Histologically confirmed high-risk or relapsed solid tumors or brain tumors, including:

• Metastatic or relapsed Ewing's sarcoma

• Metastatic or relapsed rhabdomyosarcoma

• Refractory Wilms' tumor

• Diffuse anaplastic Wilms' tumor

• Stage III or IV neuroblastoma

• Recurrent retinoblastoma

• Metastatic or relapsed germ cell tumors

• Metastatic or relapsed other soft tissue sarcomas

• Small cell ovarian sarcoma

• Metastatic or relapsed primitive neuroectodermal tumors of the bone

• Recurrent brain tumors

• Desmoplastic small round cell tumors

• Recurrent or metastatic chordomas

• Metastatic or relapsed hepatoblastoma

• Patients receive peripheral blood stem cell transplantation only if in complete remission or in very good partial remission with no disease progression

• Must have radiologic, nuclear image, or histologic verification of relapse

• Age 1 to 45

• Performance status:Karnofsky 70-100%

• Absolute neutrophil count greater than 1,000/mm^3

• Platelet count greater than 100,000/mm^3

• Hemoglobin count at least 10 g/dL

• Bilirubin less than 2 times upper limit of normal (ULN)

• SGOT or SGPT less than 2.5 times ULN

• Creatinine less than 2 times ULN

• Creatinine clearance greater than 70 mL/min

• Cardiac shortening fraction greater than 30%

• Cardiac ejection fraction greater than 45%

• At least 1 week since prior hematopoietic growth factor and recovered

• At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

• Recovered from any prior therapy

Exclusion Criteria:

• Osteogenic sarcoma

• Less than 4 months

• Uncontrolled bleeding

• Congestive heart failure

• Uncontrolled hypertension

• Asthma

• Pregnant or nursing

• Uncontrolled metabolic disease

• Active severe infection

• Allergy to aminothiol compounds

• Prior bone marrow transplantation

• Other concurrent investigational agents