Chemotherapy for Relapsed Epstein Barr Virus Associated Lymphoma

Conditions

• Epstein Barr Virus Associated Hodgkin's Lymphoma
• Epstein Barr Virus Associated Non Hodgkin's Lymphoma
• Post-Transplant Lymphoproliferative Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Doxorubicin — DRUG
  Doxorubicin 20 mg/m2 intravenously will be administered on Day 1 in patients with systemic (non-primary CNS) lymphoma as per institutional guidelines
• Methotrexate — DRUG
  Methotrexate administered starting on Day 2, per study protocol.
• Leucovorin — DRUG
  Leucovorin administered first intravenously 24 hours after start of Methotrexate infusion, then orally every 6 hours for at least 10 doses, per study protocol.
• Hydroxyurea — BIOLOGICAL
  Hydroxyurea administered orally twice daily starting on Day 2, and continuing for a total of 10 doses, per study protocol
• Zidovudine — DRUG
  Zidovudine administered first intravenously on Day 2, and then orally twice daily for 10 doses, per study protocol.
• Rituximab — DRUG
  Rituximab is optional and will be administered to study participants, per study protocol.

Study Details

By combining a variety of agents that potentiate Zidovudine (ZDV), the investigators hope to induce remission in this generally fatal disease. Most therapies for aggressive B cell lymphomas are based upon intensive chemotherapeutic regimens, expensive modalities (bone marrow transplant, Rituximab), or experimental approaches (gene therapy, cytotoxic T cell infusion) that are difficult to implement in heavily pre-treated patients. Therapy for relapsed aggressive B cell lymphomas is very poor. Even curable lymphomas such as Burkitt Lymphoma (BL) and Hodgkin lymphoma are extremely difficult to treat in relapse and/or after stem cell transplant failure. The investigators propose a novel therapeutic approach that exploits the presence of Epstein-Barr virus (EBV) in lymphomas; antiviral mediated suppression of NF-kB and disruption of viral latency.

Key Dates

First listed

Oct 17, 2013

Start date

Apr 21, 2009

Status verified

Aug 2019

Primary completion

Jun 7, 2018

Completion

Jun 7, 2018

Study Design

Enrollment

6 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Chemotherapy + Antiviral-Based Therapy
  Combination Chemotherapy for up to six (6) 21-day cycles and Antiviral-Based Therapy: * Chemotherapy: Up to 6 cycles, 21 days each: * Doxorubicin: 20 mg/m2 intravenously (IV) on Day 1 per study protocol; * Rituximab: 375mg/m2 (optional) IV on Day 1 per study protocol; * Methotrexate: 3.5 gm/m2 IV on Day 2 per study protocol; * Leucovorin: 10 mg/m2 IV starting approximately 24 hours after start of Methotrexate infusion, and then 25 mg orally every 6 hours for at least 10 doses per study protocol; * Antiviral-Based Therapy * Zidovudine: Starting 750 mg/m2 IV on Day 2, then 1200 mg orally twice daily for 10 doses per study protocol; * Hydroxyurea: 1,000 mg orally twice daily starting Day 2 for a total of 10 doses per study protocol.

Primary Outcome Measure

Rate of Complete Response to Protocol Therapy [ Time Frame: About 21 days ]

Locations (2)

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