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

Status:

WITHDRAWN

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

Lead Sponsor:

Oncotherapeutics

Conditions:

Stage II Multiple Myeloma

Stage III Multiple Myeloma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 a...

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 res...

Eligibility Criteria

Inclusion

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

Exclusion

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00085345

Last Update

July 10 2013

Active Locations (19)

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Page 1 of 5 (19 locations)

Palo Verde Hematology Oncology

Glendale, Arizona, United States, 85304

Comprehensive Blood and Cancer Center

Bakersfield, California, United States, 93309-0633

Southbay Oncology / Hematology Medical Group