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Stage IV MelanomaPhase 1NCT00498979

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

A Phase 1 study testing recombinant interferon alfa-2b, cisplatin and sodium stibogluconate in people with Stage IV Melanoma, run by Case Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stage IV Melanoma
What is being tested?
recombinant interferon alfa-2b, cisplatin and sodium stibogluconate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
May 2007to Jan 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • Potassium ≤ 5.0 mmol/L
  • Magnesium ≤ 2.4 mg/dL
  • Creatinine clearance ≥ 60 cc/min
  • Ejection fraction ≥ 50%
  • Prior interferon therapy is allowed if administered ≥ 4 months ago
  • At least 3 weeks since prior major surgery, radiation therapy, or chemotherapy

Who cannot join

  • 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)
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  • 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:
  • 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
  • Patients taking the following medications will not be eligible:
  • Amiodarone (Cordarone)
  • Disopyramide (Norpace)
  • Dofetilide (Tikosyn)
  • Procainamide (Procanbid or Pronestyl)
  • Quinidine (Quinaglute)
  • Sotalol (Betapace)
  • Erythromycin
  • Azithromycin (Z-pack)
  • Clarithromycin (Biaxin)
  • Pentamidine (Pentacarinat)
  • Trimethoprim-sulfamethoxazole (Bactrim)
  • Bepridil (Vascor)
  • Phenothiazines (e.g., prochlorperazine [Compazine], promethazine [Phenergan], or chlorpromazine [Thorazine])
  • Butyrophenones (e.g., Haloperidol [Haldol])
  • Risperidone (Risperdal)
  • Any other antipsychotic medication
  • Tricyclic or tetracyclic antidepressants (e.g., imipramine [Tofranil], amitriptyline [Elavil], desipramine [Norpramin], or nortriptyline [Pamelor])
  • Monoamine oxidase inhibitors
  • High-dose methadone
  • Arsenic trioxide
  • Dolasetron (Anzemet)
  • Any herbal preparations
  • Use of daily glucocorticoids except for physiological replacement

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cleveland Clinic Taussig Institute, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: Phase I Evaluation of Sodium Stibogluconate in Combination With Interferon α-2b Followed by Cisplatin, Vinblastine and Dacarbazine for Patients With Melanoma or Malignancies Potentially Responsive to SSG and/or Interferons

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.

Read the detailed description

OBJECTIVES:

Primary

  • To determine the safety of the combination of sodium stibogluconate and interferon alfa-2b with chemotherapy.
  • To confirm the activity of sodium stibogluconate in augmenting cytokine effects.

Secondary

  • To quantify the effects of sodium stibogluconate on interferon alfa-2b induced gene modulation and signal transduction pathways by measuring the serum soluble gene products.
  • To define the effectiveness of sodium stibogluconate in inhibiting the protein tyrosine phosphatases SHP-1 and SHP-2 assayed from peripheral blood leukocytes of patients receiving sodium stibogluconate in combination with interferon alfa-2b.
  • To define the pharmacokinetics of sodium stibogluconate in serum at escalating doses.
  • To assess clinical response to the combination of sodium stibogluconate and interferon alfa-2b as priming for combination chemotherapy.

OUTLINE:

  • Course 1: Patients receive sodium stibogluconate IV over 15 minutes on day 1 and days 15-18; interferon alfa-2b subcutaneously (SC) on days 8-12 and 15-18; cisplatin IV over 30-60 minutes and vinblastine IV on days 19 and 20; and dacarbazine. After a 2-week rest period, patients proceed to course 2.
  • Course 2 and all subsequent courses: Patients receive sodium stibogluconate IV over 15 minutes and interferon alfa-2b SC on days 1-4; cisplatin IV over 30-60 minutes and vinblastine IV on days 5 and 6; dacarbazine. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.* NOTE: *Patients with stage IV disease who have no evidence of disease [NED} receive only 4 courses of therapy.

Cohorts of 6 patients receive escalating doses of sodium stibogluconate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which dose-limiting toxicity occurs (i.e., no more than 1 patient at a given dose experiences DLT).

Patients undergo blood sample collection periodically for immunological and pharmacokinetic studies. Samples are analyzed for serum soluble gene products and protein tyrosine phosphatase inhibition.

Being tested
recombinant interferon alfa-2b, cisplatin, sodium stibogluconate, dacarbazine, vinblastine
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
Medical subject headings
Melanoma, Astrocytoma, Glioblastoma, Ependymoma, Glioma, Subependymal, Oligodendroglioma, Glioma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • recombinant interferon alfa-2bBiological

    Also called IFN 2b

    recombinant interferon alfa-2b

  • cisplatinDrug

    Also called CDDP

    recombinant interferon alfa-2b

  • sodium stibogluconateDrug

    sodium stibogluconate

  • dacarbazineDrug

    Also called DTIC

    dacarbazine

  • vinblastineDrug

    Also called VBL

    vinblastine

Study groups in NCT00498979
Study groupRoleWhat they receive
recombinant interferon alfa-2bExperimentalrecombinant interferon alfa-2b
Receives: Biological: recombinant interferon alfa-2b; Drug: cisplatin; Drug: sodium stibogluconate; Drug: dacarbazine; Drug: vinblastine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 2 years

Secondary outcomes (4)

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

    Measured: 2 years

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

    Measured: 2 years

  3. Pharmacokinetics of sodium stibogluconate in serum at escalating doses

    Measured: 2 years

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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionMay 2010
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00498979
Sponsor's protocol ID
CASE3Y06
Status last verified
Jul 2020
First submitted
10 Jul 2007
Last updated
24 Jul 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing recombinant interferon alfa-2b, cisplatin and sodium stibogluconate in people with Stage IV Melanoma, run by Case Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of the combination of sodium stibogluconate and interferon alfa-2b with chemotherapy (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00498979.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.

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