National Cancer Institute HIV/AIDS Cancer Programs Mostafa Nokta, MD Ph.D. Chief, AIDS Cancer Clinical Program Office of HIV and AIDS Malignancy National.

National Cancer Institute HIV/AIDS Cancer

Programs

Mostafa Nokta, MD Ph.D.

Chief, AIDS Cancer Clinical Program

Office of HIV and AIDS Malignancy

National Cancer Institute

Nati

onal

Can

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nstit

ute

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Cancers in HIV Disease

AIDS-Defining Virus Kaposi’s Sarcoma HHV-8 Non-Hodgkin’s Lymphoma EBV, HHV-8

(systemic and CNS) Invasive Cervical Carcinoma HPVNon-AIDS Defining Anal Cancer HPV Hodgkin’s Disease EBV Leiomyosarcoma (pediatric) EBV Squamous Conjunctival Carcinoma HPV (?) Hepatoma HBV, HCV

Change in Incidence of Cancers in HIV in the cART Era in USA

Kaposi’s sarcoma CNS Lymphoma Lymphoma (NHL and CNS) Lymphoma (HD) Anal Cancer Lung Cancer Cervical Cancer Breast Hepatoma

Patel P et al, Ann Intern Med 2008;148:728-736

Dual Burden of KSHV and HIV Infection in Africa Fuel an Epidemic of Kaposi’s Sarcoma

HIV KS KS Incidence

Office of HIV & AIDS Malignancy

AIDS Malignancy Program

AIDS Cancer Clinical Program

• CFAR• WIHS• MACS• IeDEA• AITRP

• AIDS Malignancy Consortium (AMC)• ACSR•INCTR•ACTG• SPOREs (Lung, Lymphoma, Head & Neck)

AIDS Malignancy Clinical Trials Consortium

AIDS Malignancy Consortium (AMC)

Evaluate clinical interventions for the treatment and prevention of malignancies in people with HIV

Investigate the biology of these malignancies in the context of clinical trials

Conduct Phase I, II and III clinical trials Address issues of international importance in HIV

associated malignancies Contribute specimens and clinical data to the

ACSR

AMC International Objectives

Assist with capacity building in developing nations for international HIV-related cancers

Develop AMC-sponsored and co-sponsored collaborative studies with emphasis on trials that:

- Employ hypothesis-driven, scientifically sound, locally relevant and feasible therapies

- Address important pathogenesis-based questions - Utilize the unique scientific expertise of the AMC

Current International Protocols

Protocol Project Site(s) CommentAMC 049 Sunitinib in AIDS KS Uganda, Kenya Active

AMC 050 KSHV viral transcription Brazil Active

AMC 054 Quadrivalent HPV vaccine IndiaLocal Gov

Review

AMC 055 Indinavir endemic KS Uganda Active

AMC 056 Indinavir endemic KS ZimbabweCTEP/IRB

review

AMC/ACTG 5263/5264

Treatment of early and late KS

Several sites in Africa

In development

AMCOral chemo and Modified

CHOP for AIDS NHLTBD In development

AMC International Sites

Uganda, Kampala Kenya, Nairobi Zimbabwe, Harare India, Mumbai, Chennai, Tamil Nadu Brazil, Sao Paulo Australia, Darling Hurst, NSW Dr. Mostafa Nokta, Noktam@mail.nih.gov

Dr. Ron Mitsuyasu, RMitsuya@mednet.ucla.edu

ACSR Mission

To provide high-quality HIV-associated malignancy specimens to qualified

investigators at little or no cost

ACSR Specimens• > 500,000 specimens and growing• Twenty different diagnosis codes (CA and controls)• Types of specimens

– Frozen tissues – PBMCs– Plasma– Body fluids (e.g., saliva, urine, CSF) – Formalin – fixed tissues

• Associated Clinical Data

West Coast CoastMid-Mid-RegionRegion

East East CoastCoast

ACSR Representation

“Collections” within the ACSR

• TMAs (NHL, KS)

• AMC studies

• WIHS Study

• HIV multi-site autopsies

• SF Gay men’s KS epidemiology study (Martin et al.)

• International specimens– Thailand HIV+ Plasma (vaccine study)

– Rwandan women (WIHS)

– Ugandan KS and natural history (Martin et. Al.)

ACS “Resource”

• Searchable on the Web – http://acsr.ucsf.edu

• Facilitate collaborations with investigators and specimen sources

• Procurement of requested specimens if not in the ACSR collection

Dr. Mike McGrath MMcGrath@php.ucsf.edu

Comprehensive Cancer Centers

Cancer Centers

Planning Centers

Cancer Centers

Dr. Hasnaa Shafikshafikh@mail.nih.gov

International Network for Cancer Treatment and Research

• The INCTR is a non for profit, non governmental organization dedicated to helping to build capacity for cancer treatment and research in countries with limited resources.

• Capacity building, Palliative care and educational programs• Disease interests: NH lymphoma, cervical cancer

Dr. Ian Magrath, PIhttp://www.inctr.org/

NCI/OHAM Cofunded Programs

MACS, Multicenter AIDS Cohort Study WIHS, The Women's Interagency HIV Study CFARs, Centers for AIDS Research IeDEA, International Epidemiologic Databases

to Evaluate AIDS AITRP, AIDS International Training

and Research Program

CFAR Map

Dr. Geraldina Dominguezdomingug@mail.nih.gov

• Australia• Cambodia• India• Indonesia• Japan• China• Malaysia• Singapore• Thailand

Region 5: Australia, India, Pakistan, Asia

• Burundi• Cameroon• Central African Republic• Congo, Dem. Rep. of (Zaire)• Congo, Republic of• Rwanda

Region 8: Central Africa

• Botswana• Malawi• Mozambique• South Africa• Zambia• Zimbabwe

Region 8: Southern Africa

• Kenya• Tanzania• Uganda

Region 8: East Africa

• Argentina• Brazil• Chile• Haiti• Honduras• Peru•Mexico

Region 2: Latin America & Caribbean

Region 1: North America Canada• United States

Region 8: West Africa

• Mali• Nigeria• Senegal

• Benin• Cote d'Ivoire• Gambia

NCI NICHD

Funding Opportunities for AIDS Malignancies

Research on Malignancies in the Context of HIV/AIDS (R01 and R21)

http://grants.nih.gov/grants/guide/pa-files/PA-07-454.html and

http://grants.nih.gov/grants/guide/pa-files/PA-07-455.html

Research on Non-AIDS Defining Cancers & AIDS-associated Malignancies

Tentative

Hepatocellular Carcinoma

PA-08-243 R01 (Research Grants)http://grants.nih.gov/grants/guide/pa-files/PA-08-243.html

PA-08-244 R21 (Exploratory/Developmental Grants) http://grants.nih.gov/grants/guide/pa-files/PA-08-244.html

• PAR-08-245 P01 (Program Project Grants) http://grants.nih.gov/grants/guide/pa-files/PAR-08-245.html

Capacity Building

RFA: Strengthening Capacity for HIV-Associated Malignancies in Africa

PI from a US institution and an African Institution

Will support training in all disciplines from basic to clinical research to lay the foundation for the African/US investigators to seek future independent research grants on AIDS-related cancers

International Conference on Malignancies in AIDS & Other Acquired Immunodeficiencies

12th ICMOI, April 26 & 27, 2010 Bethesda, MD, USA

For more Information: Contact: Dr. Rebecca Huppi, liddellr@exchange.nih.gov Ms. Denise Jenkins, Jenkinde@mail.nih.gov

HIV Cancer Resources

Office of HIV and AIDS Malignancy

(OHAM) WEB Site

http://oham.cancer.gov/

Enhance Collaborations