Fludarabine/Carboplatin/Topotecan w/Thalidomide for Relapsed/Refractory AML, CML and MDS

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. Combining chemotherapy with thalidomide may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining fludarabine, carboplatin, and topotecan with thalidomide in treating patients who have relapsed or refractory acute myeloid leukemia, chronic myelogenous leukemia, or advanced myelodysplastic syndromes.

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

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Fludarabine; Fludarabine phosphate; Thalidomide; Topotecan; Vidarabine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following:

• Acute myeloid leukemia meeting 1 of the following criteria:

• Previously untreated and not a candidate for anthracycline-based chemotherapy

• In first or second relapse or refractory

• Secondary to chemotherapy or an antecedent hematologic disorder and treated with no more than 1 prior intensive induction regimen

• Chronic myelogenous leukemia in blast crisis at diagnosis or after prior imatinib mesylate

• Myelodysplastic syndromes (MDS)

• Refractory anemia with excess blasts (RAEB) or RAEB in transformation

• Must meet at least 1 of the following criteria:

• Absolute neutrophil count no greater than 500/mm^3

• Platelet or red cell transfusion-dependent after no more than 1 prior intensive induction chemotherapy

• Acute promyelocytic leukemia

• t(15, 17)

• Failed prior treatment with tretinoin and arsenic

• Relapsed disease at least 3 months after prior autologous stem cell transplantation

• No active CNS leukemia

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-3

Life expectancy

• At least 8 weeks

Hematopoietic

• See Disease Characteristics

Hepatic

• Bilirubin no greater than 2.0 mg/dL

• AST and ALT less than 3 times upper limit of normal

Renal

• Creatinine clearance at least 50 mL/min

Cardiovascular

• Ejection fraction at least 40%

• No poorly controlled cardiac disease

Pulmonary

• No poorly controlled pulmonary disease

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile female patients must use 1 highly effective and 1 additional method of contraception for 4 weeks before, during, and for at least 4 weeks after study

• Male patients must use effective contraception during and for 4 weeks after study

• Willing and able to comply with the System for Thalidomide Education and Prescribing Safety (STEPS) program

• HIV negative

• No poorly controlled infection

• No other active malignancy

• No severe peripheral neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

• Prior thalidomide allowed for MDS

• At least 5 days since prior hematopoietic growth factors

• At least 2 weeks since prior biologic therapy

• No prior allogeneic bone marrow transplantation

Chemotherapy

• See Disease Characteristics

• At least 24 hours since prior hydroxyurea

Endocrine therapy

• At least 24 hours since prior corticosteroids

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• At least 2 weeks since prior cytotoxic anticancer therapy

• Prior amifostine allowed for MDS