Clinical trial · Interventional
Polyglutamate Camptothecin in Treating Patients With Advanced Cancer
Phase I Study of CT-2106 in Patients With Advanced Malignancy
NCT00059917CI-TRIAL-00010474completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy such as polyglutamate camptothecin may be able to deliver the drug directly to tumor cells while leaving normal cells undamaged. PURPOSE: Phase I trial to study the effectiveness of polyglutamate camptothecin in treating patients who have advanced cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| polyglutamate camptothecin | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed advanced malignancy * No active brain metastases (as indicated by clinical symptoms, cerebral edema, or progressive tumor growth) that have been unstable for at least 8 weeks PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST and ALT no greater than 2.5 times ULN (5 times ULN if liver metastases are present) Renal * Creatinine no greater than 1.5 times ULN * No history of hemorrhagic cystitis * No history of microscopic hematuria associated with drug therapy or radiotherapy or of unknown origin Cardiovascular * No significant cardiac disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to comply with study schedule and assessments * No other significant nonmalignant systemic disease * No active infection * No other condition that would in the investigator's opinion make the patient an inappropriate study candidate PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No more than 3 prior chemotherapy regimens * More than 4 weeks since prior chemotherapy Endocrine therapy * Not specified Radiotherapy * More than 4 weeks since prior definitive radiotherapy (except for palliative reasons to sites of nonmeasurable disease, in patients with measurable disease at baseline) * Concurrent palliative radiotherapy allowed Surgery * More than 4 weeks since prior major thoracic or abdominal surgery Other * Recovered from prior therapy (except alopecia or stable grade 1 neuropathy) * More than 4 weeks since prior investigational agents * No prior myeloablative therapy
References
Publications (2)
- RESULTMcNamara MV, Doroshow JH, Dupont J, et al.: Preliminary pharmacokinetics of CT-2106 (polyglutamate camptothecin) in patients with advanced malignancies. [Abstract] J Clin Oncol 22 (Suppl 14): A-2073, 145s, 2004.
- RESULTSpringett GM, Takimoto C, McNamara M, et al.: Phase I study of CT-2106 (polyglutamate camptothecin) in patients with advanced malignancies. [Abstract] J Clin Oncol 22 (Suppl 14): A-3127, 226s, 2004.