Status:
TERMINATED
Sodium Stibogluconate and Interferon in Treating Patients With Advanced Solid Tumors, Lymphoma, or Myeloma
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Sodium stibogluconate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Interferon may interfere with the growth of cancer cells. Giving sodium sti...
Detailed Description
OBJECTIVES: Primary * Confirm the tolerance, safety, and maximum tolerated dose of sodium stibogluconate (SSG) in combination with interferon alfa-2b in patients with advanced solid tumors, lymphoma...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed malignancy, including, but not limited to, any of the following:
- Renal cell carcinoma
- Melanoma
- Kaposi's sarcoma
- Breast, prostate, colorectal, or lung adenocarcinoma
- Bone and soft tissue sarcomas
- Lymphoma
- Myeloma
- Tumors of neuroendocrine and endothelial cell origin
- Stage IV disease
- Refractory disease, resistant to established treatments, or no effective treatment available
- Measurable or evaluable disease
- CNS metastases allowed if no prior definitive therapy within the past 3 months and no glucocorticoids required
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Granulocyte count \> 1,500/mm\^3
- Platelet count \> 100,000/mm\^3
- Creatinine \< 1.0 times upper limit of normal (ULN)
- Creatinine clearance ≥ 60 mL/min
- Bilirubin \< 1.5 times ULN
- AST/ALT \< 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- No history of any of the following:
- Atrial fibrillation, atrial flutter, or other serious arrhythmia (excluding asymptomatic atrial and ventricular premature complexes)
- Congestive heart failure currently requiring treatment
- Angina pectoris
- Other severe cardiovascular disease (i.e., New York Heart Association class III or IV heart disease)
- No baseline ECG abnormalities suggestive of cardiac conduction delay, i.e., 1° or greater atrio-ventricular block and/or complete or incomplete (QRS \> 120 ms) bundle branch block, or repolarization abnormalities (i.e., QTc ≥ 0.48 sec)
- No systemic infections requiring antibiotics within the past 14 days
- No known hepatitis B surface antigen positivity
- Psychologically prepared to participate in study treatment
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 weeks since prior interferon (IFN) therapy and/or ≤ 400 million units of IFN
- At least 3 weeks since prior major surgery
- At least 3 weeks since prior radiation therapy or chemotherapy
- No prior solid organ allografts or allogeneic bone marrow transplantation
- No concurrent daily glucocorticoids except for physiological replacement
- No other concurrent medications known to prolong QT interval
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00311558
Start Date
October 1 2005
End Date
January 1 2012
Last Update
January 26 2018
Active Locations (1)
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1
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195