Sodium Stibogluconate and IFNa-2b Followed By CDDP, VLB and DTIC Treating Pts.With Advanced Melanoma or Other Cancers

NCT00498979 | Completed Phase 1 DMC

• 1 other identifier: CASE3Y06
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Sodium stibogluconate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma and other cancers. Drugs used in chemotherapy, such as cisplatin, vinblastine, and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sodium stibogluconate and interferon alfa-2b together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of sodium stibogluconate when given together with interferon alfa-2b, cisplatin, vinblastine, and dacarbazine in treating patients with advanced melanoma or other cancer.

Conditions

Stage IV Melanoma

Keywords

stage IV melanoma; adult anaplastic astrocytoma; adult diffuse astrocytoma; adult glioblastoma; adult giant cell glioblastoma; adult pilocytic astrocytoma; adult brain stem glioma; adult anaplastic ependymoma; adult ependymoma; adult myxopapillary ependymoma; adult subependymoma; adult anaplastic oligodendroglioma; adult oligodendroglioma; mixed gliomas; recurrent adult brain tumor; recurrent melanoma; adult gliosarcoma; adult subependymal giant cell astrocytoma; adult pineal gland astrocytoma

Outcome Measures

Primary Outcomes (1)

• Safety of the combination of sodium stibogluconate and interferon alfa-2b with chemotherapy

  2 years

Secondary Outcomes (4)

• Effects of sodium stibogluconate on interferon alfa-2b induced gene modulation and signal transduction pathways by measuring the serum soluble gene product

  2 years

• Effectiveness of sodium stibogluconate in inhibiting the protein tyrosine phosphatases SHP-1 and SHP-2 assayed from peripheral blood leukocytes

  2 years

• Pharmacokinetics of sodium stibogluconate in serum at escalating doses

  2 years

• Clinical response to the combination of sodium stibogluconate and interferon alfa-2b as priming for combination chemotherapy

  2 years

Study Arms (1)

recombinant interferon alfa-2b

EXPERIMENTAL

recombinant interferon alfa-2b

Biological: recombinant interferon alfa-2b; Drug: cisplatin; Drug: sodium stibogluconate; Drug: dacarbazine; Drug: vinblastine

Interventions

recombinant interferon alfa-2b BIOLOGICAL

recombinant interferon alfa-2b

Also known as: IFN 2b

recombinant interferon alfa-2b

cisplatin DRUG

recombinant interferon alfa-2b

Also known as: CDDP

recombinant interferon alfa-2b

sodium stibogluconate DRUG

sodium stibogluconate

recombinant interferon alfa-2b

dacarbazine DRUG

dacarbazine

Also known as: DTIC

recombinant interferon alfa-2b

vinblastine DRUG

vinblastine

Also known as: VBL

recombinant interferon alfa-2b

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG performance status 0-2
• Granulocytes \> 1,500/μl
• Platelets \> 100,000/μl
• Creatinine \< 1.5 x upper limit of normal (ULN)
• Bilirubin \< 1.5 x ULN
• AST and ALT \< 1.5 x ULN (unless due to hepatic metastases)
• Potassium ≤ 5.0 mmol/L
• Magnesium ≤ 2.4 mg/dL
• Creatinine clearance ≥ 60 cc/min
• Ejection fraction ≥ 50%

You may not qualify if:

• Pregnant or lactating women and fertile women or men unless surgically sterile or using effective contraception
• All female patients of childbearing potential or less than 1 year postmenopausal must have a negative β-HCG pregnancy test at baseline and practice a medically acceptable method of birth control (i.e., oral contraceptives for at least 3 months, implantation of an intrauterine device for at least 2 months, or barrier methods \[e.g., vaginal diaphragm, vaginal sponge, or condom with spermicidal jelly\]) during and for 3 months after study initiation
• History of atrial fibrillation, flutter, or other serious arrhythmia (excluding asymptomatic atrial or ventricular premature complexes) in the past 24 months
• History of congestive heart failure currently requiring treatment; angina pectoris; or other severe cardiovascular disease (i.e., New York Heart Association class III or IV heart disease)
• Baseline ECG abnormalities suggestive of cardiac conduction delay (i.e., first degree or greater atrio-ventricular block and/or complete or incomplete \[QRS \> 120 ms\] bundle branch block)
• Baseline ECG abnormalities suggestive of repolarization abnormalities (i.e., QTc ≥ 0.48 sec)
• Culture positive acute infections requiring antibiotics within the past 14 days
• Patients on long term suppressive antibiotic therapies are eligible
• Known to be positive for HBsAg
• Patients judged to not be psychologically prepared to understand informed consent or comply with an investigational study
• PRIOR CONCURRENT THERAPY:
• Prior interferon therapy is allowed if administered ≥ 4 months ago
• At least 3 weeks since prior major surgery, radiation therapy, or chemotherapy
• No prior treatment with interferon, sodium stibogluconate, cisplatin, vinblastine, or dacarbazine, except if given in an adjuvant setting
• Patients with a prior history of solid organ allografts or allogeneic bone marrow transplant

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Melanoma; Astrocytoma; Glioblastoma; Ependymoma; Glioma, Subependymal; Oligodendroglioma; Glioma; Brain Neoplasms; Gliosarcoma

Interventions

Introns; Cisplatin; Antimony Sodium Gluconate; Dacarbazine; Vinblastine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms, Neuroepithelial; Neoplasms, Glandular and Epithelial; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Organic Chemicals; Gluconates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Ernest C. Borden, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 11, 2007
• Study Start: May 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: January 1, 2012
• Last Updated: July 24, 2020

Record last verified: 2020-07

Locations

US (1)