Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma

• 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. Vitamin C may increase the effectiveness of arsenic trioxide by making cancer cells more sensitive to the drug.

PURPOSE: Phase I/II trial to determine the effectiveness of arsenic trioxide plus vitamin C in treating patients who have recurrent or refractory multiple myeloma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Collaborator: National Cancer Institute (NCI)
• Treatments: Arsenic Trioxide; Ascorbic Acid

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed multiple myeloma

• M-protein by serum protein electrophoresis or urine protein electrophoresis

• Quantitative determination of immunoglobulin

• Bone marrow biopsy and aspirate with a plasma cell count greater than 10%

• Refractory or chemoresistant disease defined as failure to respond (less than 50% reduction in M protein level) or progression within 2 months after receiving at least 2 chemotherapy regimens including:

• Alkylating based regimen (melphalan) in combination with steroids (prednisone) or other chemotherapy regimens (e.g., vincristine, bleomycin, melphalan, cyclophosphamide, and prednisone or vincristine, carmustine, doxorubicin, and prednisone)

• Vincristine, doxorubicin, and dexamethasone (VAD) regimen

• Pulse therapy with high dose steroids alone

• High dose alkylating agent and autologous stem cell transplantation

• Allogeneic bone marrow transplantation

• Plateau phase defined as M protein in the serum or urine for more than 6 weeks despite response to prior therapy

• Must have received at least 2 of the chemotherapy regimens listed above or equivalent regimens

• Recurrent disease defined as progression more than 2 months after initial therapy and failure to respond (less than 50% reduction or progression in M protein levels) to 1 chemotherapy regimen listed above or other salvage regimens (e.g., high-dose cyclophosphamide or topotecan)

• Must have received VAD or other equivalent chemotherapy regimen

• Should be considered for autologous or allogenic transplantation

• Prior local radiotherapy allowed

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 2,000/mm^3*

• Platelet count at least 50,000/mm^3* NOTE: *Unless attributable to bone marrow infiltration by multiple myeloma

Hepatic:

• Bilirubin less than 3 mg/dL

• Transaminases less than 2.5 times upper limit of normal (ULN)

Renal:

• Creatinine less than 1.5 times ULN OR

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No cardiac arrhythmias including recurrent supraventricular arrhythmia, any type of sustained ventricular arrhythmia, or conduction block (atrioventricular block grade II or III, left bundle branch block)

• Ejection fraction at least 30%

• No uncontrolled ischemic heart disease

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception during and for 4 months after study

• HIV negative

• No grade 3 or higher neurological disorder, including seizure disorders

• No underlying medical condition that would preclude study

• No other active malignancy except adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

Chemotherapy:

• See Disease Characteristics

• At least 2 weeks since prior chemotherapy

Endocrine therapy:

• See Disease Characteristics

• Concurrent steroid treatment allowed except for primary treatment of myeloma

Radiotherapy:

• See Disease Characteristics

• Concurrent local radiotherapy for pain or symptom control allowed provided the pain or symptom is not related to disease progression

Surgery:

• Not specified

Other:

• No other concurrent ascorbic acid supplements

• No other concurrent investigational drug or therapy

• Concurrent bisphosphonates allowed