Status:
COMPLETED
Arsenic Trioxide and Ascorbic Acid Combined With Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Multiple Myeloma and Plasma Cell Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 divid...
Detailed Description
OBJECTIVES: Primary * Determine the dose-limiting toxicity of arsenic trioxide when given in combination with ascorbic acid, bortezomib, thalidomide, and dexamethasone, particularly in terms of sens...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed multiple myeloma (MM) or plasma cell leukemia meeting 1 of the following criteria:
- Relapsed or refractory disease after treatment with prior effective therapy
- Exhibited \< a partial response to the last therapy
- Measurable disease, defined by 1 of the following:
- Serum M protein ≥ 1.0 g/dL
- Urine M-protein ≥ 500 mg/24 hours
- Plasmacytoma with bidimensional measurements on CT scan or MRI (each axis ≥ 1 cm)
- Previously treated with ≥ 1 induction chemotherapy regimen for MM
- No known CNS involvement by multiple myeloma
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Zubrod or SWOG 0-2 OR
- Karnofsky 60-100%
- Life expectancy
- More than 12 weeks
- Hematopoietic
- WBC ≥ 1,500/mm\^3
- Absolute neutrophil count ≥ 1,000/mm\^3
- Platelet count ≥ 80,000/mm\^3
- Hemoglobin ≥ 8.5 g/dL
- No history of heparin-induced thrombocytopenia
- Low blood counts allowed if marrow is heavily infiltrated by multiple myeloma
- Hepatic
- Bilirubin ≤ 1.5 times upper limit normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- Renal
- Creatinine ≤ 2.5 mg/dL
- Cardiovascular
- QTc \< 480 msec on EKG in the presence of serum potassium ≥ 4.0 mEq/dL and serum magnesium ≥ 1.8 mg/dL
- LVEF ≥ 55% by ECHO or MUGA
- No prior deep vein thrombosis, unless on concurrent anticoagulation
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No history of ventricular arrhythmia
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- No history of allergic reactions or severe adverse reactions attributed to compounds of similar chemical or biological composition to study drugs
- No other malignancy in the past 2 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix
- No peripheral neuropathy ≥ grade 2
- No ongoing or active infection requiring IV antibiotics
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
- Controlled HIV disease allowed as long as there are no associated comorbid complications
- No active peptic ulcer disease
- No other condition that would confer a high risk of bleeding complications
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- More than 4 weeks since prior thalidomide or lenalidomide for MM
- Prior autologous or allogeneic stem cell transplant for MM allowed
- Concurrent hematopoietic growth factors (e.g., epoetin alfa, filgrastim \[G-CSF\]) for MM allowed
- Chemotherapy
- See Disease Characteristics
- More than 4 weeks since prior arsenic trioxide for MM
- Endocrine therapy
- More than 4 weeks since prior corticosteroids for MM
- Radiotherapy
- More than 4 weeks since prior therapeutic radiotherapy (e.g., to plasmacytomas)
- Palliative radiotherapy for painful symptomatic lytic skeletal lesions allowed within the past 4 weeks
- Surgery
- Not specified
- Other
- More than 4 weeks since prior cytotoxic agents or other therapy (e.g., bortezomib) for MM
- More than 30 days (or 5 half-lives) since prior investigational agents
- Concurrent bisphosphonates for MM allowed
- No other concurrent anticancer therapy
- No other concurrent investigational agents
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00258245
Start Date
May 1 2005
End Date
April 1 2008
Last Update
April 29 2013
Active Locations (1)
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1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379