Clinical trial · Interventional
Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer
A Phase II Randomized Discontinuation Trial Of Carboxyaminoimidazole (CAI, NSC 609974) In Metastatic Renal Carcinoma
NCT00006486CI-TRIAL-00008921completedPhase 2ClinicalTrials.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)
Randomized phase II trial to study the effectiveness of carboxyamidotriazole in treating patients who have metastatic kidney cancer. Carboxyamidotriazole may stop the growth of kidney cancer by stopping blood flow to the tumor
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage IV Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboxyamidotriazole | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (carboxyaminoimidazole)
- description
- Patients receive oral CAI daily for 4 weeks. Treatment repeats for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients experiencing complete or partial response continue treatment until disease progression or unacceptable toxicity. Patients receive oral CAI as above.
- interventionNames
- Drug: carboxyamidotriazole
- type
- EXPERIMENTAL
- label
- Arm II (carboxyamidotriazole, placebo)
- description
- Patients receive oral CAI daily for 4 weeks. Treatment repeats for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients experiencing complete or partial response continue treatment until disease progression or unacceptable toxicity. Patients receive a placebo.
- interventionNames
- Drug: carboxyamidotriazole
- Other: placebo
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed renal cell carcinoma
* Metastatic or unresectable disease
* Documented disease progression, even after nephrectomy
* At least 1 unidimensionally measurable lesion
* At least 20 mm by conventional techniques
* At least 10 mm by spiral CT scan
* The following lesions are not considered measurable:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Abdominal masses not confirmed and followed by imaging
* Cystic lesions
* Performance status - CTC 0-2
* WBC at least 2,000/mm\^3
* Platelet count at least 75,000/mm\^3
* Bilirubin no greater than upper limit of normal (ULN)
* AST no greater than 2.5 times ULN
* Creatinine no greater than 2.0 mg/dL
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No baseline neuropathy or cerebellar dysfunction greater than grade 1
* At least 4 weeks since prior immunotherapy
* No prior carboxyamidotriazole
* No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
* Concurrent epoetin alfa allowed
* At least 4 weeks since prior chemotherapy
* No concurrent chemotherapy
* No concurrent hormonal therapy except steroids for adrenal failure or hormones for conditions not related to disease (e.g., insulin for diabetes)
* At least 4 weeks since prior radiotherapy
* No concurrent palliative radiotherapy
* See Disease Characteristics
* At least 4 weeks since prior surgeryReferences
Publications (0)
Data not yet available
No reference posted for this study.