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

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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