Melphalan, Arsenic Trioxide, and Ascorbic Acid in Treating Patients With Relapsed or Refractory Multiple Myeloma

• Status: Withdrawn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

Summary

RATIONALE: Drugs used in chemotherapy, such as melphalan, arsenic trioxide, and ascorbic acid, work in different ways to stop cancer cells from dividing so they stop growing or die. Arsenic trioxide and ascorbic acid may also help melphalan kill more cancer cells by making them more sensitive to the drugs.

PURPOSE: This phase II trial is studying how well giving melphalan together with arsenic trioxide and ascorbic acid works in treating patients with relapsed or refractory multiple myeloma.

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

Details

• Lead Sponsor: Oncotherapeutics
• Treatments: Arsenic Trioxide; Ascorbic Acid; Melphalan

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of multiple myeloma meeting at least 1 of the following criteria:

• Relapsed disease after a response to standard first-line chemotherapy (e.g., vincristine, doxorubicin, and dexamethasone [VAD] OR melphalan and prednisone) or first-line high-dose chemotherapy

• Refractory disease (failed to achieve at least stable disease) to most recent chemotherapy with or without systemic corticosteroids

• Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of ≥ 1 g/dL AND/OR urine monoclonal immunoglobulin spike of ≥ 200 mg/24 hours

• No non-secretory myeloma

• No plasma cell leukemia

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• More than 3 months

Hematopoietic

• Platelet count ≥ 50,000/mm^3 (30,000/mm^3 if bone marrow is extensively infiltrated)

• Hemoglobin ≥ 8.0 g/dL

• Absolute neutrophil count ≥ 1,000/mm^3

• Pancytopenia secondary to multiple myeloma or hypersplenism allowed

Hepatic

• AST and ALT ≤ 3 times upper limit of normal (ULN)

• Bilirubin ≤ 2 times ULN (unless clearly related to disease)

• No known active hepatitis B or C infection

Renal

• Calcium < 14 mg/dL

Cardiovascular

• No evidence of acute ischemia or new conduction system abnormality by electrocardiogram

• No myocardial infarction within the past 6 months

• No New York Heart Association class III or IV heart failure

• No poorly controlled hypertension

• No prolonged corrected QT interval (> 460 ms) with potassium > 4 mmol/L and magnesium ≥ 1.8 mmol/L

Other

• No active infection

• No POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)

• No diabetes mellitus

• No other serious medical or psychiatric illness that would preclude study participation

• No known allergic reaction attributable to compounds of similar chemical or biological composition to study drugs

• No history of grand mal seizures

• HIV negative

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 4 weeks since prior immunotherapy or antibody therapy

Chemotherapy

• See Disease Characteristics

• More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy

• See Disease Characteristics

• No other concurrent corticosteroids

Radiotherapy

• More than 4 weeks since prior radiotherapy

Surgery

• More than 4 weeks since prior major surgery

Other

• No other concurrent investigational agents