SGN-00101 in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia

February 8, 2013 updated by: National Cancer Institute (NCI)

A Phase I/II Trial of SGN-00101 in the Treatment of High-Grade Anal Intraepithelial Neoplasia (AIN) in HIV-Positive Individuals

Phase I/II trial to study the effectiveness of SGN-00101 in preventing anal cancer in HIV-positive patients who have high-grade anal neoplasia. Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. SGN-00101 may be effective in preventing anal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

I. Determine the safety and maximum tolerated dose of SGN-00101 in HIV-positive patients with high-grade anal squamous intraepithelial lesions.

II. Determine clinical response and histologic/cytologic regression in patients treated with this drug.

III. Determine immune response in patients treated with this drug. IV. Determine the effect of this drug on HIV viral load and CD4 level in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive SGN-00101 subcutaneously once on weeks 0, 4, and 8. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 5-6 patients receive escalating doses of SGN-00101 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experience dose-limiting toxicity.

Patients are followed at 1, 4, and 10 months.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • UCSF Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed high-grade anal squamous intraepithelial lesions (HSIL) with residual HSIL of the anal canal or margin by high-resolution anoscopy

    • Declined routine surgery or not a candidate for surgical excision of HSIL

  • Documented evidence of HIV infection by one of the following methods:

    • Serologic (ELISA or western blot)
    • Culture
    • Quantitative polymerase chain reaction or bDNA assays
  • HIV RNA no greater than 500 copies/mL
  • CD4 at least 200 x 10^6/L

  • Must have received stable highly active antiviral therapy (HAART) for at least 4 weeks before study

    • HAART defined as 3 or more agents, including a protease inhibitor or nonnucleoside reverse transcriptase inhibitor that is approved or available through expanded access combination antiviral therapy
  • No prior history of invasive anal or cervical cancer
  • No concurrent untreated cervical HSIL

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Life expectancy

  • At least 12 months

Hematopoietic

  • Hemoglobin at least 10 g/dL
  • Platelet count at least 75,000/mm^3
  • Absolute neutrophil count at least 1,000/mm^3

Hepatic

  • AST and ALT no greater than 3 times upper limit of normal (ULN)

Renal

  • Creatinine no greater than 1.5 times ULN

Immunologic

  • No prior severe allergic reactions (i.e., anaphylactic response) to drugs or any other allergen
  • No history of collagen-vascular or autoimmune disorder requiring treatment within the past 5 years
  • No other concurrent illness that compromises the immune system
  • No active serious opportunistic infection

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 forms of effective contraception during and for 3 months after study
  • No concurrent participation in a conception process (e.g., active attempt to become pregnant or impregnate, sperm donation, or in vitro fertilization)
  • No other concurrent medical or psychiatric illness that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent immunostimulants (including interferon or interleukin-12)

Chemotherapy

  • More than 1 year since prior chemotherapy for cancer

Endocrine therapy

  • No concurrent steroids that compromise immune function

    • Concurrent topical corticosteroids allowed if dose determined not to suppress immune function

Radiotherapy

  • More than 1 year since prior radiotherapy for cancer

Other

  • More than 30 days since other prior investigational agents
  • No concurrent medications that suppress immune function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm I

Patients receive SGN-00101 subcutaneously once on weeks 0, 4, and 8. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 5-6 patients receive escalating doses of SGN-00101 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experience dose-limiting toxicity.
Biological: HspE7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (ACTUAL)

July 1, 2005

Study Registration Dates

First Submitted

January 24, 2003

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

February 11, 2013

Last Update Submitted That Met QC Criteria

February 8, 2013

Last Verified

April 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02507
  • AMC-035
  • CDR0000258786 (REGISTRY: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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