Solid Tumors Clinical Trial
Official title:
A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sodium Stibogluconate in Combination With Interferon Alpha-2b for Patients With Advanced Malignancies
Primary Objective:
-To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of SSG in
combination with IFN alpha2b in patients with advanced malignancies.
Secondary Objectives:
- To correlate the AUC of SSG with clinical toxicity and efficacy.
- To quantify the effect of SSG on IFN alpha2b induced gene modulation and signal
transduction pathways.
- To characterize the effects of SSG on PTPases SHP-1 and SHP-2.
- To assess the safety, efficacy, and PK of SSG in combination with IFN alpha2b.
Sodium stibogluconate is a drug that is able to block an enzyme in the cells that is
responsible for cell growth. By blocking this enzyme, it may be able to prevent cancer cells
from multiplying.
Interferon alfa-2b is a drug that activates an immune response to infections in the body. By
triggering an immune response, this drug may help to prevent some cancer cells from growing
and multiplying. You will receive treatment with both sodium stibogluconate and interferon
alfa-2b, because sodium stibogluconate may improve the effectiveness of interferon in
treating the cancer.
Participants will be enrolled in groups of 3 on this study, and the doses of the study drugs
will be escalated for each group. This means that each new group of 3 participants will get a
higher dose of the study drugs than the group before them. This will continue until the
highest tolerable dose combination is found.
Once the highest tolerable dose has been found, up to an additional 9 participants, called
the expansion group, will receive study drug at that dose. Your doctor will tell you if you
are in the expansion group.
If you are found to be eligible to take part in this study, you will go to the clinic to
start treatment. During Cycle 1, you will be given sodium stibogluconate once a day by vein
during Days 1-5. On Days 8-12, you will be given sodium stibogluconate once a day by vein,
and you will be given interferon alfa-2b for 3 days by injection just under the skin on Days
8, 10, and 12. For every cycle after Cycle 1, you will be given sodium stibogluconate once a
day by vein during Days 1-5 and 8-12, and you will be given interferon alfa-2b for 3 days by
injection just under the skin on Days 1, 3,5, 8, 10, and 12. Treatment cycles will last about
3 weeks (2 weeks on treatment, followed by 1 week off treatment).
During each visit to the clinic, you will be asked how you are feeling, and your vital signs
will be measured. You will have a complete physical exam the first day of every cycle. On
Days 1, 8, and 12 of every cycle, you will have a urine test to check the function of your
kidneys, and blood (about 3 teaspoons) will be drawn for routine tests. On Days 1, 8, and 12
of every cycle and during your last study visit, you will have an additional blood draw
(about 5 teaspoons) for immunological testing (to help researchers learn how your body fights
disease) before treatment. On Days 1, 5, 8, and 12 of every cycle, you will have an ECG after
you receive treatment.
At some time during the week before Day 1 of Cycle 1 and on Day 12 of Cycle 2, you may have a
tumor biopsy to check the status of the disease before you receive the study drug. To perform
a tumor biopsy, the affected area is numbed with anesthetic, and a small amount of tumor
tissue is withdrawn through a large needle. Your doctor will tell you if this may be
necessary.
On Days 1, 2, 9, 12, and 13 of Cycle 1, you will have blood drawn (about 1 teaspoon each) for
PK testing. On Days 1, 8, and 12, the PK testing will be done before, 30 minutes after, and 2
hours after you receive the study drug. On Days 2 and 9, the PK testing will be done before
treatment. On Day 13, the PK testing will be done 24 hours after you received treatment on
Day 12.
After Cycle 1, you will be scheduled to return to the clinic in 10 days to receive treatment
for Cycle 2, which will follow in the same manner as Cycle 1.
At the end of Cycle 2 and every even-numbered cycle (Cycles 4, 6, 8, and so on) after that,
you will have imaging studies, such as x-rays and CT scans, to check the status of your
tumors.
If the disease does not get worse and you do not experience any intolerable side effects
after Cycle 1, you will continue on to Cycle 2, and so on. If at any time the disease gets
worse or you experience any intolerable side effects, you will be taken off this study.
This is an investigational study. Sodium stibogluconate is not FDA approved or commercially
available. It is authorized for use in research only. Interferon alfa-2b is approved by the
FDA for the treatment of some types of cancers (solid tumors). The combination of these drugs
is investigational in this study. Their use together is authorized for use in research only.
However, if sodium stibogluconate becomes commercially available while you are still on
study. Up to 54 patients will take part in this multicenter study. Up to 35 will be enrolled
at M. D. Anderson.
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