Arsenic Trioxide, Ascorbic Acid, Dexamethasone, and Thalidomide in Treating Patients With Multiple Myeloma

NCT00112879 | Withdrawn Phase 2

• 4 other identifiers: CCF-IRB-7469CDR0000428248CCF-IRB-5241CCF-CTI-T12016
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving arsenic trioxide together with ascorbic acid, dexamethasone, and thalidomide may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with ascorbic acid, dexamethasone, and thalidomide work in treating patients with multiple myeloma.

Conditions

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

Interventions

arsenic trioxide DRUG

ascorbic acid DRUG

dexamethasone DRUG

thalidomide DRUG

anti-cytokine therapy PROCEDURE

antiangiogenesis therapy PROCEDURE

biological therapy PROCEDURE

chemotherapy PROCEDURE

drug resistance inhibition PROCEDURE

growth factor antagonist therapy PROCEDURE

non-specific immune-modulator therapy 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 (MM), meeting 1 of the following criteria: * Previously untreated disease with poor prognosis, meeting 1 of the following criteria: * Active disease with β2 microglobulin ≥ 5.5 mg/dL * Inactive disease with peripheral plasma cells OR chromosome 13 or 14 abnormalities by fluorescent in situ hybridization * Relapsed or refractory disease * Measurable disease by serum and urine M-protein and/or measurable plasmacytoma PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2\* NOTE: \*ECOG 3 allowed for patients with bone pain due to MM Life expectancy * At least 3 months Hematopoietic * Platelet count ≥ 75,000/mm\^3 unless plasma cells \> 50% in bone marrow * Any WBC allowed provided plasma cells \> 50% in bone marrow Hepatic * SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) * Bilirubin ≤ 2.5 times ULN Renal * Creatinine ≤ 6.0 mg/dL Cardiovascular * Absolute QT interval ≤ 460 msec with potassium ≥ 4.0 mEq/L AND magnesium ≥ 1.8 mg/dL * No conduction defects * No unstable angina * No myocardial infarction within the past 6 months * No congestive heart failure * No New York Heart Association class II-IV heart disease * No other significant underlying cardiac dysfunction Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double-method contraception for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study therapy * No blood, ova, or sperm donation during study participation * No history of grand mal seizures except infantile febrile seizures * No pre-existing neurotoxicity or neuropathy ≥ grade 2 * No uncontrolled diabetes mellitus * No active serious infection that cannot be controlled with antibiotics * No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer * No other condition that would preclude study compliance or follow up PRIOR CONCURRENT THERAPY: Biologic therapy * Prior thalidomide allowed (in patients with relapsed or refractory MM) * No prior thalidomide in combination with arsenic trioxide * Prior epoetin alfa allowed Chemotherapy * See Biologic therapy * Prior arsenic trioxide allowed (for patients with relapsed or refractory MM) * No concurrent cytotoxic chemotherapy * No chemotherapy within 2 weeks after completion of study treatment Endocrine therapy * Prior steroid therapy allowed (for patients with relapsed or refractory MM) Radiotherapy * No concurrent broad-field radiotherapy Surgery * Not specified Other * Prior and concurrent bisphosphonates allowed * 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

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Arsenic Trioxide; Ascorbic Acid; Dexamethasone; Thalidomide; Biological Therapy; 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; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics

Study Officials

• Mohamad A. Hussein, MD

  The Cleveland Clinic

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: June 2, 2005
• First Posted: June 3, 2005
• Last Updated: July 10, 2013

Record last verified: 2006-12

Locations

US (1)