Rebeccamycin Analog in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, or Chronic Myelogenous Leukemia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial is studying the side effects and best dose of rebeccamycin analog in treating patients with relapsed or refractory acute myeloid leukemia, myelodysplastic syndrome, acute lymphoblastic leukemia, or chronic myelogenous leukemia in blast phase. Drugs used in chemotherapy, such as rebeccamycin analog, work in different ways to stop cancer cells from dividing so they stop growing or die

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

Details

• Lead Sponsor: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• Diagnosis of 1 of the following:

• Acute myeloid leukemia

• Myelodysplastic syndromes, including 1 of the following:

• Refractory anemia with excess blasts (RAEB)

• RAEB in transformation

• Chronic myelomonocytic leukemia in transformation with ≥ 10% peripheral blood or bone marrow blasts

• Acute lymphoblastic leukemia

• Chronic myelogenous leukemia in blastic phase

• Relapsed or refractory disease, defined as 1 of the following:

• Failed to achieve a complete response (CR) to a standard induction regimen

• Relapsed after achieving a CR

• Failed last cytotoxic regimen before study entry

• No alternate, potentially curative option available

• No known CNS disease

• Performance status - ECOG 0-2

• SGOT and SGPT normal

• Bilirubin normal

• Creatinine normal

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV-positive patients with normal CD4 count and without AIDS-defining disease allowed

• No history of allergic reaction attributed to compounds of similar chemical or biologic composition to rebeccamycin analogue (XL119)

• No concurrent uncontrolled illness

• No active or ongoing infection

• No psychiatric illness or social situation that would preclude study compliance

• No prior allogeneic stem cell transplantation

• No concurrent prophylactic hematopoietic colony-stimulating factors (CSF)

• No epoetin alfa or hematopoietic CSF during course 1 of study therapy

• More than 7 days since prior cytotoxic chemotherapy except for hydroxyurea

• More than 7 days since prior radiotherapy

• Recovered from all prior therapy

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No other concurrent anticancer agents or therapies

• No other concurrent antileukemic agents or therapies

• No other concurrent investigational agents or therapies

• No other concurrent cytotoxic agents