Search / Trial NCT00001438

A Pilot Study of the Combination of Retinoic Acid and Interferon-Alpha2a for the Treatment of Lymphoproliferative Disorders in Children With Immunodeficiency Syndromes

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

Trial Information

Current as of December 07, 2024

Completed

Keywords

Hiv Infection Immune Response Pediatric Pharmacokinetics Toxicity

ClinConnect Summary

Patients with congenital or acquired immunodeficiencies are at an increased risk to develop polyclonal or oligoclonal lymphoid malignancies. Some develop a lymphoproliferative disorder that can follow a clinically aggressive course and may represent a pre-malignant lesion. Although most of these lymphoproliferative disorders are of B-cell origin, T-cell or non-B-non-T-cell processes have also been observed. The pathogenesis is only partially understood. The Epstein-Barr virus (EBV) is thought to play an important role but the human herpes virus type 6 (HHV-6) has been implicated as well. An...

Gender

ALL

Eligibility criteria

  • DISEASE CHARACTERISTICS:
  • Congenital or acquired immunodeficiency (including HIV-1 infection) with a lymphoproliferative disorder (LPD) of any of the following types:
  • Severe and/or progressive lymphadenopathy with hypergammaglobulinemia.
  • Diffuse infiltrative lymphocytosis syndrome.
  • Clinically symptomatic pulmonary lymphoid hyperplasia/lymphocytic interstitial pneumonitis.
  • Polyclonal B-cell LPD.
  • No patients with malignant lymphoma.
  • No active opportunistic infection requiring acute intervention at entry.
  • THERAPY:
  • Biologic Therapy:
  • At least 30 days since immunomodulating agents or biological response modifiers, e.g.: Interleukin-2, Interferons, Growth hormone, Insulin-like growth factor 1.
  • Requirement waived for intravenous immunoglobulins for hypogammaglobulinemia.
  • Concurrent post-transplant immunosuppressants allowed. Doses stable for at least 4 weeks prior to entry.
  • Chemotherapy: At least 30 days since chemotherapy.
  • Endocrine Therapy:
  • Concurrent corticosteroids allowed only for lymphocytic interstitial pneumonitis or an autoimmune process. Doses stable for more than 4 weeks prior to entry.
  • Radiotherapy: At least 30 days since radiotherapy.
  • Surgery: Not specified.
  • Antiretroviral therapy (in patients with HIV infection):
  • Approved anti-HIV medication required.
  • Initiated at least 8 weeks prior to entry.
  • Continued throughout protocol treatment.
  • Prophylaxis for Pneumocystis carinii pneumonia and/or Mycobacterium avium-intracellulare allowed.
  • Maintenance antifungal or antiviral therapy allowed.
  • PATIENT CHARACTERISTICS:
  • Age: Under 18.
  • Performance status: Not specified.
  • One or more of the following laboratory findings (within 4 weeks of starting retinoic acid and interferon-alpha , and which have not resolved within 2 weeks of starting):
  • Creatinine greater than 2 times the upper limit of normal;
  • Liver transaminases greater than 5 times the upper limit of normal (children with chronically elevated liver enzymes with a proven etiology can be enrolled, but will not be evaluable for liver toxicity); or
  • Bilirubin greater than 3 times the upper limit of normal.
  • Patients receiving treatment for an acute infection must have completed therapy at least 14 days prior to starting therapy with retinoic acid and interferon-alpha.
  • OTHER:
  • Able to swallow capsules.
  • No requirement for drugs suspected of causing pseudotumor cerebri for which alternatives cannot be substituted, e.g.: Tetracycline, Nalidixic acid, Nitrofurantoin, Phenytoin, Lithium, Amiodarone, Vitamin A (except as a multivitamin supplement component).
  • No critical or clinically unstable illness.
  • No pregnant or nursing women.
  • Effective contraception encouraged in fertile patients.
  • Parent or legal guardian available to give informed consent and deemed sufficiently reliable to return for followup visits.
  • No critically ill or critically unstable children.

About National Cancer Institute (Nci)

The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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