SGN-00101 in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia
A Phase I/II Trial of SGN-00101 in the Treatment of High-Grade Anal Intraepithelial Neoplasia (AIN) in HIV-Positive Individuals
Study Overview
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
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- UCSF Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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. |
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
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))
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