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| ID | Type | Description | Link |
|---|---|---|---|
| TMTX 0015 |
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To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in pediatric 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).
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trimetrexate glucuronate | Drug | |||
| Leucovorin calcium | Drug |
Inclusion Criteria
Patients must have:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Feinberg J | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United States Bioscience Inc | West Conshohocken | Pennsylvania | 19428 | United States |
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| ID | Term |
|---|---|
| D011020 | Pneumonia, Pneumocystis |
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D008172 | Lung Diseases, Fungal |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C056321 | trimetrexate glucuronate |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
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| D016720 |
| Pneumocystis Infections |
| D012141 | Respiratory Tract Infections |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
| D011621 |
| Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |