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

Primary Purpose

Anal Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HspE7
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anal Cancer focused on measuring anal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm 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.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 24, 2003
Last Updated
February 8, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00052897
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2004
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Cancer
Keywords
anal cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
HspE7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Palefsky, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

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

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