Biomarkers in Blood Samples From Patients With HIV Infection and Stage III or Stage IV Hodgkin Lymphoma Undergoing Chemotherapy

NCT01319526 | Terminated

• 2 other identifiers: AMC-079CDR0000690149
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Studying samples of blood in the laboratory from patients undergoing treatment with HIV infection and Hodgkin lymphoma may help doctors learn more about the effects of therapy on HIV. PURPOSE: This research study is studying biomarkers in blood samples from patients with HIV infection and stage III or stage IV Hodgkin lymphoma undergoing chemotherapy.

Conditions

Lymphoma; Nonneoplastic Condition

Keywords

stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; HIV infection

Outcome Measures

Primary Outcomes (1)

• Change in viral load from baseline to each subsequent time point

  Time frame for outcome measures dependent on study calendar for parent protocol, S0816, which varies by subject's PET scan status.

  Baseline, after each cycle of treatment, restaging, treatment completion, year 1, year 2, study discontinuation

Interventions

DNA analysis GENETIC

RNA analysis GENETIC

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinical trial participants (subjects who are participating in parent protocol S0816 and provide informed consent for participation in this substudy).

DISEASE CHARACTERISTICS: * HIV-1 infection, as documented by a rapid HIV test or any FDA-approved HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit and confirmed by western blot at any time prior to study entry * Documentation may be serologic (positive ELISA and positive western blot), or other federally approved licensed HIV diagnostic test * Prior documentation of HIV seropositivity is acceptable * Diagnosis of untreated Hodgkin lymphoma and participation in the parent protocol SWOG-S0816, "A Phase II Trial of Response Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging." PATIENT CHARACTERISTICS: * No psychosocial conditions that would prevent study compliance and follow-up, as determined by the principal investigator * Willing to provide serial blood samples PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• AIDS Malignancy Consortium: lead
• National Cancer Institute (NCI): collaborator
• The Emmes Company, LLC: collaborator

Study Sites (2)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

PBMC

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease; HIV Infections

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes

Study Officials

• John W. Mellors, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2010
• First Posted: March 21, 2011
• Study Start: June 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

US (2)