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A Study of Neutrexin Plus Leucovorin in the Treatment of Pneumocystis Carinii Pneumonia (PCP)



A Study of Neutrexin Plus Leucovorin in the Treatment of Pneumocystis Carinii Pneumonia (PCP)

For Condition: Pneumonia, Pneumocystis carinii,HIV Infections
Status: Completed
Sponsor(s): U.S. Bioscience ,
Synopsis: To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in patients with Pneumocystis carinii pneumonia (PCP) who are refractory to or have demonstrated severe or life-threatening toxicities to standard therapies (e.g., TMP/SMX or parenteral pentamidine).
Details: Patients receive intravenous infusions of trimetrexate glucuronate and leucovorin for 21 days. Leucovorin is continued for 3 additional days after discontinuation of trimetrexate glucuronate. Patients are followed for 1 month.
Eligibility:
Study Type:  Interventional, Treatment, Open Label, Safety Study
Minimum Age/Maximum Age: 2 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Myelosuppressive or nephrotoxic agents at the discretion of the treating physician. Patients must have: - Pneumocystis carinii pneumonia (PCP) confirmed within 15 days prior to study entry. - Serious intolerance and/or resistance to standard therapies (such as trimethoprim/sulfamethoxazole and parenteral pentamidine) during the course of therapy for the current episode of PCP, or a documented history of such intolerance during a prior episode. - Consent of parent or guardian if less than 18 years of age. NOTE: - Pregnant women may enroll after the physician and patient have discussed the potential benefit versus risk. Exclusion Criteria Patients with the following prior conditions are excluded: History of Type I hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis), exfoliative dermatitis, or other life-threatening reactions due to trimetrexate glucuronate.
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
FeinbergJ,  Study Chair, 

United States Bioscience Inc
West Conshohocken,  Pennsylvania,  19428
United States
 


Additional Information:
Study ID Numbers:  132A;  TMTX 0014
Study Start Date: 
Record last reviewed: January 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002434

Other Pneumonia, Pneumocystis Carinii Studies:
1. A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate With Leucovorin Protection for Patients With Pneumocystis carinii Pneumonia.

2. A Double-Blind Placebo-Controlled Group Comparative Study To Evaluate the Safety and Effectiveness of Aerosol Pentamidine in the Prophylaxis of Pneumocystis carinii Pneumonia in Patients With AIDS Post First Episode PCP

3. A Study of Two Forms of Pentamidine in HIV-Infected Children Who May Have Pneumocystis carinii Pneumonia

4. A Comparison of Dapsone and Trimethoprim-Sulfamethoxazole in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS

5. A Comparison of Atovaquone and Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia in HIV-Infected Patients Who Cannot Take TMP/SMX

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A Study of Neutrexin Plus Leucovorin in the Treatment of Pneumocystis Carinii Pneumonia (PCP)
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