AIDS-related Kaposi SarcomaPhase 2NCT00020683
A Phase II Trial of COL-3 in Patients With HIV Related Kaposi's Sarcoma
A Phase 2 study testing incyclinide and laboratory biomarker analysis in people with AIDS-related Kaposi Sarcoma and HIV Infection, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
COL-3 may stop the growth of cancer by stopping blood flow to the tumor. Randomized phase II trial to compare the effectiveness of two different regimens of COL-3 in treating patients who have HIV-related Kaposi's sarcoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AIDS-related Kaposi Sarcoma, HIV Infection
- What is being tested?
- incyclinide and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Nov 2009
- Phase
- Phase 2
- 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
- Biopsy proven KS involving the skin , lymph nodes, oral cavity, gastrointestinal (GI) tract and/or lungs; GI and pulmonary involvement must be asymptomatic or minimally symptomatic and not require systemic cytotoxic therapy; at least five measurable, previously non-radiated, cutaneous lesions must be present which can be used as indicator lesions
- Serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive ELISA, positive Western Blot, or other federally approved licensed HIV test
- Karnofsky performance status >= 60%
- Hemoglobin >= 8.0 gm/dl
- Absolute neutrophil count >= 750 cells/mm^3
- Platelet count >= 75,000/mm^3
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- Serum creatinine =< 1.5 mg/dl or a measured creatinine clearance of > 60 ml/min
- Total bilirubin should be normal; if, however, the elevated bilirubin is felt to be secondary to indinavir therapy, then subjects will be allowed on protocol if bilirubin < 3.5 mg/dl, provided that the direct bilirubin is normal
- AST (SGOT) and ALT (SGPT) =< 2.5 times the ULN
- PT and PTT < 120% of normal
- Life expectancy of 3 months or more
- Ability and willingness to give informed consent
- All women of childbearing potential must have a negative serum beta HCG within 72 hours prior to study entry and must practice adequate birth control to prevent pregnancy while receiving study treatment and for 3 months after treatment is discontinued; all males of child fathering potential must also practice adequate birth control; pregnant or breast feeding females are excluded from participation in this study since the effects of Col-3 on an unborn or young child are unknown and may potentially be toxic
- Subjects must, in the opinion of the investigator, be capable of complying with this protocol
Who cannot join
- Concurrent active opportunistic infection (OI)
- Concurrent neoplasia requiring cytotoxic therapy
- Acute treatment for an infection or other serious medical illness within 14 days prior to study entry
- Prior anti-neoplastic treatment for KS within 3 weeks of study entry; patients must also have completely recovered from any associated toxicity
- Previous local therapy of any KS indicator lesion within 60 days, unless the lesion has progressed since treatment; because of the possibility of tattooing and the difficulty in ascertaining clinically what is active KS versus residual pigment post treatment, any prior local treatment to the indicator lesions regardless of the elapsed time should not be allowed unless there is evidence of clear-cut progression of said lesion
- Anti-retroviral therapy is permitted but not required; if patients are taking anti-retroviral therapy, their regimen must not have changed within 4 weeks of starting the study medication; patient should be receiving an optimal and stable regimen of HAART for a minimum of 4 weeks prior to entry
- Subjects must not have received blood products within 4 weeks of study entry and must not have received granulocyte colony stimulating factor or erythropoietin within 2 weeks of study entry
- Evidence of a prior MI or cardiac ischemia
Trial locations and contacts
1 site in 1 country.
United States1 site
AIDS - Associated Malignancies Clinical Trials Consortium
Rockville, Maryland, 20850
About this study
COL-3 may stop the growth of cancer by stopping blood flow to the tumor. Randomized phase II trial to compare the effectiveness of two different regimens of COL-3 in treating patients who have HIV-related Kaposi's sarcoma.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the tumor response rate and response duration of treatment with Col-3 at two different dose levels- 50 mg/day and 100 mg/day in subjects with HIV related KS.
II. To evaluate the biologic activity of Col-3 by measuring percent apoptotic cells on tumor biopsies pre- and post-treatment.
III. To evaluate the effect of Col-3 on serum levels of MMP-2 and MMP-9.
SECONDARY OBJECTIVES:
- To determine the safety and toxicity of Col-3 at two different dose levels in HIV related KS.
II. To evaluate the effect of Col-3 on overall quality of life. III. To evaluate the relationship between clinical response and quantitative measures of KSHV/HHV-8 and HIV viral load.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive low-dose oral COL-3 once daily.
Arm II: Patients receive high-dose oral COL-3 once daily.
Treatment on both arms continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed.
Patients are followed for at least 1 month.
PROJECTED ACCRUAL: A total of 70 patients (35 per treatment arm) will be accrued for this study within 1.75 years.
- Conditions
- AIDS-related Kaposi Sarcoma, HIV Infection
- Being tested
- incyclinide, laboratory biomarker analysis
- Medical subject headings
- AIDS-related Kaposi sarcoma, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incyclinideDrug
High dose given orally
incyclinideDrug
Low dose given orally
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (low dose incyclinide) | Experimental | Patients receive low-dose oral COL-3 once daily.
Treatment on both arms continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed. Receives: Drug: incyclinide; Other: laboratory biomarker analysis |
| Arm II (high dose incyclinide) | Experimental | Patients receive high-dose oral COL-3 once daily.
Treatment on both arms continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed. Receives: Drug: incyclinide; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Binomial proportions and their 95% confidence intervals will be used to estimate the overall response rate for each treatment group.
Measured: Up to 6 years
Response duration
The Kaplan-Meier Method will be used to estimate the distribution of response duration for each treatment group.
Measured: Up to 6 years
Secondary outcomes (4)
Frequency of adverse events and their severity
Will be tabulated to evaluate tolerance of each dose level in the treatment of AIDS-related Kaposi's Sarcoma.
Measured: Up to 6 years
Time to response
The Kaplan-Meier Method will be used to estimate the distribution of time to response for each treatment group.
Measured: Up to 6 years
Quality of life
Individual composite scores will be constructed. Repeated measures and an analysis of variance will be performed on the composite scores to evaluate changes with time. Mixed models will be applied to the analysis of the composite score.
Measured: Up to 6 years
Relationship between clinical response and quantitative measures of KSHV/HHV8 and HIV viral load
These measures will be tested to determine if they are normally distributed. If the data are non-normal, the data will be transformed for analysis purposes. The logistic regression model will be used to assess the relationship between qualification of baseline levels of KSHV/HHV-8, HIV viral load and response. The proportional hazards model will be used to evaluate the relationship between the qualification of baseline KSHV/HHV8 and HIV viral load and time to progression, and response duration.
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 2003
- Primary completionNov 2005
- Study completionNov 2009
Why it stopped: Cancer Therapy Evaluation Program's (CTEP's) termination of drug supply
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIDS-related Kaposi SarcomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Bruce Dezube, Principal investigator, AIDS Associated Malignancies Clinical Trials Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00020683
- Sponsor's protocol ID
- NCI-2012-02924
- Other IDs
- NCI-2012-02924, CDR0000068703, AMC-027, AMC-027, U01CA070019
- Status last verified
- Oct 2018
- First submitted
- 11 Jul 2001
- Last updated
- 18 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of COL-3 in Patients With HIV Related Kaposi's Sarcoma
- ClinicalTrials.gov ID
- NCT00020683
- Acronym / sponsor ID
- NCI-2012-02924
- Conditions
- AIDS-related Kaposi Sarcoma, HIV Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Cancer Therapy Evaluation Program's (CTEP's) termination of drug supply
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Mar 2003 (actual)
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
COL-3 may stop the growth of cancer by stopping blood flow to the tumor. Randomized phase II trial to compare the effectiveness of two different regimens of COL-3 in treating patients who have HIV-related Kaposi's sarcoma.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the tumor response rate and response duration of treatment with Col-3 at two different dose levels- 50 mg/day and 100 mg/day in subjects with HIV related KS.
II. To evaluate the biologic activity of Col-3 by measuring percent apoptotic cells on tumor biopsies pre- and post-treatment.
III. To evaluate the effect of Col-3 on serum levels of MMP-2 and MMP-9.
SECONDARY OBJECTIVES:
- To determine the safety and toxicity of Col-3 at two different dose levels in HIV related KS.
II. To evaluate the effect of Col-3 on overall quality of life. III. To evaluate the relationship between clinical response and quantitative measures of KSHV/HHV-8 and HIV viral load.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive low-dose oral COL-3 once daily.
Arm II: Patients receive high-dose oral COL-3 once daily.
Treatment on both arms continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed.
Patients are followed for at least 1 month.
PROJECTED ACCRUAL: A total of 70 patients (35 per treatment arm) will be accrued for this study within 1.75 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (low dose incyclinide) | Experimental | Drug: incyclinide, Other: laboratory biomarker analysisPatients receive low-dose oral COL-3 once daily. Treatment on both arms continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed. |
| Arm II (high dose incyclinide) | Experimental | Drug: incyclinide, Other: laboratory biomarker analysisPatients receive high-dose oral COL-3 once daily. Treatment on both arms continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Biopsy proven KS involving the skin , lymph nodes, oral cavity, gastrointestinal (GI) tract and/or lungs; GI and pulmonary involvement must be asymptomatic or minimally symptomatic and not require systemic cytotoxic therapy; at least five measurable, previously non-radiated, cutaneous lesions must be present which can be used as indicator lesions
- Serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive ELISA, positive Western Blot, or other federally approved licensed HIV test
- Karnofsky performance status >= 60%
- Hemoglobin >= 8.0 gm/dl
- Absolute neutrophil count >= 750 cells/mm^3
Key exclusion criteria (8 listed)
- Concurrent active opportunistic infection (OI)
- Concurrent neoplasia requiring cytotoxic therapy
- Acute treatment for an infection or other serious medical illness within 14 days prior to study entry
- Prior anti-neoplastic treatment for KS within 3 weeks of study entry; patients must also have completely recovered from any associated toxicity
- Previous local therapy of any KS indicator lesion within 60 days, unless the lesion has progressed since treatment; because of the possibility of tattooing and the difficulty in ascertaining clinically what is active KS versus residual pigment post treatment, any prior local treatment to the indicator lesions regardless of the elapsed time should not be allowed unless there is evidence of clear-cut progression of said lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| incyclinideHigh dose given orally | Drug | Arm II (high dose incyclinide) |
| incyclinideLow dose given orally | Drug | Arm I (low dose incyclinide) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (low dose incyclinide), Arm II (high dose incyclinide) |
Primary outcome
Overall response rate
Time frame: Up to 6 years
Binomial proportions and their 95% confidence intervals will be used to estimate the overall response rate for each treatment group.
Response duration
Time frame: Up to 6 years
The Kaplan-Meier Method will be used to estimate the distribution of response duration for each treatment group.
4 secondary outcomes
Frequency of adverse events and their severity
Time frame: Up to 6 years
Time to response
Time frame: Up to 6 years
Quality of life
Time frame: Up to 6 years
Relationship between clinical response and quantitative measures of KSHV/HHV8 and HIV viral load
Time frame: Up to 6 years
Results and safety
The study was stopped early (reason given: Cancer Therapy Evaluation Program's (CTEP's) termination of drug supply). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
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Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Dezube principal investigator
AIDS Associated Malignancies Clinical Trials Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing incyclinide and laboratory biomarker analysis in people with AIDS-related Kaposi Sarcoma and HIV Infection, run by National Cancer Institute (NCI) 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 14 inclusion and 8 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: stopped early, as of the sponsor's last update on 18 Oct 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Cancer Therapy Evaluation Program's (CTEP's) termination of drug supply). Results are not available in the source record.
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?
Overall response rate (time frame: Up to 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2018; AzTrials last refreshed its copy on 7 Nov 2026.