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

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stage II Multiple Myeloma; Stage III Multiple Myeloma; Refractory Plasma Cell Neoplasm

Intervention: arsenic trioxide (Drug); ascorbic acid (Drug); melphalan (Drug); chemosensitization/potentiation (Procedure); chemotherapy (Procedure)

Phase: Phase 2

Status: Withdrawn

Sponsored by: Oncotherapeutics

Official(s) and/or principal investigator(s):
James R. Berenson, MD, Study Chair, Affiliation: Oncotherapeutics

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.

Clinical Details

Official title: Phase II Study of Melphalan, Arsenic Trioxide, and Ascorbic Acid in Patients With Relapsed or Refractory Multiple Myeloma

Study design: Primary Purpose: Treatment

Detailed description: OBJECTIVES: Primary

- Determine the time to progression in patients with relapsed or refractory multiple

myeloma (MM) treated with melphalan, arsenic trioxide, and ascorbic acid.

- Determine the response rate (combined complete response, partial response, and minimal

response) in patients treated with this regimen.

- Determine the safety and tolerability of this regimen in these patients.

Secondary

- Determine the time to response and overall survival of patients treated with this

regimen.

- Determine the effects of this regimen on renal failure associated with MM in these

patients. OUTLINE: This is an open-label, non-randomized, multicenter study. Patients receive oral melphalan once daily on days 1-4 of week 1 and arsenic trioxide (ATO) IV over 1-2 hours and ascorbic acid IV over 15 minutes on days 1-4 of week 1 and then twice weekly during weeks 2-5. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression any time after course 1 also receive oral prednisone once daily on days 1-4 and 22-25 of each course. Patients achieving a complete response after 6 courses of therapy undergo bone marrow biopsy and receive no further therapy. Patients achieving stable disease or a partial response after 6 courses of therapy continue to receive ATO and ascorbic acid once weekly. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Palo Verde Hematology Oncology, Glendale, Arizona 85304, United States

Comprehensive Blood and Cancer Center, Bakersfield, California 93309-0633, United States

Southbay Oncology / Hematology Medical Group, Campbell, California 95008, United States

Fountain Valley, California 92708, United States

Hematology-Oncology Medical Group of Fresno, Incorporated, Fresno, California 93720, United States

Hematology Oncology Medical Group of Orange County, Incorporated, Orange, California 92868, United States

Cancer Care Associates Medical Group - Redondo Beach, Redondo Beach, California 90277, United States

Redwood Regional Oncology Center - Sotoyome, Santa Rosa, California 95405, United States

Cancer Prevention and Treatment Center at Dominican and Watsonville Community Hospital, Soquel, California 95073, United States

San Diego Cancer Center - Vista, Vista, California 92083, United States

Oncotherapeutics, West Hollywood, California 90069, United States

Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center, Miami Beach, Florida 33140, United States

Atlanta Cancer Care - Roswell, Roswell, Georgia 30076, United States

Tulane Cancer Center at Tulane University Hospital and Clinic, New Orleans, Louisiana 70112-2699, United States

Center for Cancer and Blood Disorders at Suburban Hospital, Bethesda, Maryland 20817, United States

William Beaumont Hospital - Royal Oak Campus, Royal Oak, Michigan 48073, United States

Hackensack University Medical Center Cancer Center, Hackensack, New Jersey 07601, United States

Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania 19104-4283, United States

Utah Cancer Specialists - Administrative Office, Salt Lake City, Utah 84106, United States

Additional Information


Last updated: July 9, 2013

Page last updated: August 23, 2015

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