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

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Brief Title

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

Official Title

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

Brief Summary

      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.
    

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 Phase

Phase 1/Phase 2

Study Type

Interventional




Condition

Anal Cancer

Intervention

HspE7

Study Arms / Comparison Groups

 Arm I
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

18

Start Date

December 2002


Primary Completion Date

July 2005

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Joel Palefsky, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00052897

Organization ID

NCI-2012-02507

Secondary IDs

AMC-035

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Joel Palefsky, MD, Study Chair, University of California, San Francisco


Verification Date

April 2004