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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00052897
First received: January 24, 2003
Last updated: February 8, 2013
Last verified: April 2004
  Purpose

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.


Condition Intervention Phase
Anal Cancer
Biological: HspE7
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase I/II Trial of SGN-00101 in the Treatment of High-Grade Anal Intraepithelial Neoplasia (AIN) in HIV-Positive Individuals

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Enrollment: 18
Study Start Date: December 2002
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052897

Locations
United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94143
Sponsors and Collaborators
Investigators
Study Chair: Joel Palefsky, MD University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00052897     History of Changes
Other Study ID Numbers: NCI-2012-02507, AMC-035, CDR0000258786
Study First Received: January 24, 2003
Last Updated: February 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
anal cancer

Additional relevant MeSH terms:
Anus Neoplasms
Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 15, 2014