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

NCT00085345 | Withdrawn Phase 2

• 2 other identifiers: ONCOTHER-MAC001CDR0000368637
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 19

Brief 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.

Conditions

Stage II Multiple Myeloma; Stage III Multiple Myeloma; Refractory Plasma Cell Neoplasm

Interventions

arsenic trioxide DRUG

ascorbic acid DRUG

melphalan DRUG

chemosensitization/potentiation PROCEDURE

chemotherapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Oncotherapeutics: lead

Study Sites (19)

Palo Verde Hematology Oncology

Glendale, Arizona, 85304, United States

Location

Comprehensive Blood and Cancer Center

Bakersfield, California, 93309-0633, United States

Location

Southbay Oncology / Hematology Medical Group

Campbell, California, 95008, United States

Location

Unknown Facility

Fountain Valley, California, 92708, United States

Location

Hematology-Oncology Medical Group of Fresno, Incorporated

Fresno, California, 93720, United States

Location

Hematology Oncology Medical Group of Orange County, Incorporated

Orange, California, 92868, United States

Location

Cancer Care Associates Medical Group - Redondo Beach

Redondo Beach, California, 90277, United States

Location

Redwood Regional Oncology Center - Sotoyome

Santa Rosa, California, 95405, United States

Location

Cancer Prevention and Treatment Center at Dominican and Watsonville Community Hospital

Soquel, California, 95073, United States

Location

San Diego Cancer Center - Vista

Vista, California, 92083, United States

Location

Oncotherapeutics

West Hollywood, California, 90069, United States

Location

Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Atlanta Cancer Care - Roswell

Roswell, Georgia, 30076, United States

Location

Tulane Cancer Center at Tulane University Hospital and Clinic

New Orleans, Louisiana, 70112-2699, United States

Location

Center for Cancer and Blood Disorders at Suburban Hospital

Bethesda, Maryland, 20817, United States

Location

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, 48073, United States

Location

Hackensack University Medical Center Cancer Center

Hackensack, New Jersey, 07601, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Utah Cancer Specialists - Administrative Office

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Arsenic Trioxide; Ascorbic Acid; Melphalan; Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Therapeutics

Study Officials

• James R. Berenson, MD

  Oncotherapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Last Updated: July 10, 2013

Record last verified: 2006-07

Locations

US (19)