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NCT00005655 · ClinicalTrials.gov registry record · Phase 1
Combination Therapy of Interleukin-12 and Interleukin-2 to Treat Advanced Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT00005655: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00005655 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00005655, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
The purposes of this study are fourfold. It will 1) determine what dose of interleukin-12 (IL-12) and interleukin-2 (IL-2) combination therapy can be given safely to patients with advanced cancer; 2) evaluate the side effects of this treatment; 3) examine how the body handles this drug combination; and 4) determine whether and how the therapy may cause the immune system to stop or slow tumor growth. IL-2 is an approved drug for treating melanoma and kidney cancer. IL-12 is an experimental drug that has shown anti-cancer activity in animals, shrinking tumors and slowing their growth. Animal studies suggest that given together, the drugs may be more effective against cancer than either one singly. Patients 18 years of age and older with advanced solid-tumor cancers (kidney, breast, lung, sarcomas and others) that do not improve with standard treatment may qualify for this study. Candidates will have a physical examination, including blood and urine tests, electrocardiogram (EKG) and echocardiogram, DTH skin test (to test the function of the immune system), chest X-ray and lung function tests to determine eligibility. Bone marrow biopsy and imaging procedures such as CT and MRI scans may also be required. Patients over 50 years old will also undergo exercise stress testing. Treatment will consist of four courses of IL-2 and IL-12. On days one and nine of each course, patients will receive three doses (one every 8 hours) of IL-2 intravenously (through a vein). On days two, four, six, 10, 12 and 14, they will receive IL-12 intravenously. This will be followed by a recovery period from days 15 through 35. This regimen will be repeated for another three cycles; patients who show benefit without severe side effects may continue for additional cycles. Treatment for the first cycle will be administered in the hospital. If the drugs are well tolerated, additional therapy may be given on an outpatient basis. A biopsy (removal of a small sample of tumor tissue) will be done
Interventions
- BIOLOGICAL rh IL-12
- BIOLOGICAL rh IL-2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2000-04-28 |
| Est. Completion | 2017-03-02 |
| Phase | Phase 1 |
Why NCT00005655 stopped before completion
NCT00005655 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 2 interventions - of which rh IL-12 is the first listed.
NCT00005655 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00005655 about?
NCT00005655 is a clinical study titled "Combination Therapy of Interleukin-12 and Interleukin-2 to Treat Advanced Cancer". The purposes of this study are fourfold. It will 1) determine what dose of interleukin-12 (IL-12) and interleukin-2 (IL-2) combination therapy can be given safely to patients with advanced cancer; 2) evaluate the side effects of this treatment; 3) examine how the body handles this drug combination; ...
What is the current status of trial NCT00005655?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2000-04-28. Estimated completion is 2017-03-02.
What interventions are being tested in trial NCT00005655?
The interventions under investigation include: rh IL-12 (BIOLOGICAL), rh IL-2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00005655?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00005655's enrollment target sits among peer trials
39 1191st of 2000 higher than 804 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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