NCT00020683

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2003

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

October 18, 2018

Status Verified

October 1, 2018

Enrollment Period

2.7 years

First QC Date

July 11, 2001

Last Update Submit

October 17, 2018

Conditions

AIDS-related Kaposi SarcomaHIV Infection

Outcome Measures

Primary Outcomes (2)

  • Overall response rate

    Binomial proportions and their 95% confidence intervals will be used to estimate the overall response rate for each treatment group.

    Up to 6 years

  • Response duration

    The Kaplan-Meier Method will be used to estimate the distribution of response duration for each treatment group.

    Up to 6 years

Secondary Outcomes (4)

  • Frequency of adverse events and their severity

    Up to 6 years

  • Time to response

    Up to 6 years

  • Quality of life

    Up to 6 years

  • Relationship between clinical response and quantitative measures of KSHV/HHV8 and HIV viral load

    Up to 6 years

Study Arms (2)

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.

Drug: incyclinideOther: 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.

Drug: incyclinideOther: laboratory biomarker analysis

Interventions

incyclinideDRUG

High dose given orally

Arm II (high dose incyclinide)
laboratory biomarker analysisOTHER

Correlative studies

Arm I (low dose incyclinide)Arm II (high dose incyclinide)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIDS - Associated Malignancies Clinical Trials Consortium

Rockville, Maryland, 20850, United States

Location

MeSH Terms

Conditions

AIDS-related Kaposi sarcomaHIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Bruce Dezube

    AIDS Associated Malignancies Clinical Trials Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

March 1, 2003

Primary Completion

November 1, 2005

Study Completion

November 1, 2009

Last Updated

October 18, 2018

Record last verified: 2018-10

Locations

US(1)