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Phase I Evaluation of Sodium Stibogluconate in Combination With Interferon α-2b for Solid Tumors, Lymphoma or Myeloma

Phase 1
18 Years
Open (Enrolling)

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Trial Information

Phase I Evaluation of Sodium Stibogluconate in Combination With Interferon α-2b for Solid Tumors, Lymphoma or Myeloma



- 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, or myeloma.


- Quantify the effect of SSG on interferon alfa-2b-induced gene modulation and signal
transduction pathways by measurement of the serum-soluble gene products β-2
microglobulin, immune serum globulin 15, and neopterin.

- Define the effectiveness of SSG in inhibiting the protein tyrosine phosphatases src
homology proteins (SHP)-1 and SHP-2 assayed from peripheral blood leukocytes of
patients receiving SSG in combination with interferon alfa-2b.

- Define pharmacokinetics of SSG in serum at escalating doses.

- Assess clinical response to the combination of SSG and interferon alfa-2b.

OUTLINE: This is an open-label, dose-escalation study of sodium stibogluconate (SSG).

Patients receive SSG IV over 15 minutes on days 1, 15-19, and 22-26 and interferon alfa-2b
subcutaneously daily on days 8-12 and 15-28. Treatment repeats every 6 weeks in the absence
of disease progression or unacceptable toxicity.

Cohorts of 6 patients receive escalating doses of SSG until the maximum tolerated dose (MTD)
is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed malignancy, including, but not limited to, any of the

- 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

- Measurable or evaluable disease

- CNS metastases allowed if no prior definitive therapy within the past 3 months and no
glucocorticoids required


- 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


- See Disease Characteristics

- At least 4 weeks since prior interferon (IFN) therapy and/or ≤ 400 million units of

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tolerance, safety, and maximum tolerated dose at 1 week after each course

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Ernest C. Borden, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

October 2005

Completion Date:

May 2012

Related Keywords:

  • Cancer
  • stage IV melanoma
  • stage IV adult soft tissue sarcoma
  • recurrent melanoma
  • Lymphoma



Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195