Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Prevention	Completed	18 and over	NCI	AMC-035 NCT00052897

Objectives

1. Determine the safety and maximum tolerated dose of SGN-00101 in HIV-positive patients with high-grade anal squamous intraepithelial lesions.
2. Determine clinical response and histologic/cytologic regression in patients treated with this drug.
3. Determine immune response in patients treated with this drug.
4. Determine the effect of this drug on HIV viral load and CD4 level in these patients.

Entry 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 10⁶/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

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

Surgery

• See Disease Characteristics

Other

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Not specified

Life expectancy

• At least 12 months

Hematopoietic

• Hemoglobin at least 10 g/dL
• Platelet count at least 75,000/mm³
• Absolute neutrophil count at least 1,000/mm³

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

Expected Enrollment

A total of 5-18 patients will be accrued for this study within 1-6 months.

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.

Trial Contact Information

Trial Lead Organizations

AIDS Associated Malignancies Clinical Trials Consortium

Joel Palefsky, MD, Protocol chair		Ph: 415-476-1574; 800-888-8664

Registry Information
Official Title		A Phase I/II Trial of SGN-00101 in the Treatment of High-Grade Anal Intraepithelial Neoplasia (AIN) in HIV-Positive Individuals
Trial Start Date		2002-12-16
Registered in ClinicalTrials.gov		NCT00052897
Date Submitted to PDQ		2002-11-05
Information Last Verified		2004-04-26
NCI Grant/Contract Number		U01-CA70019

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