Phase 2 Completed N=26 Treatment

Tretinoin Plus Interferon Alfa in Treating Patients With Metastatic Kidney Cancer

Source: ClinicalTrials.gov NCT00003656 ↗

Enrolled (actual)

Serious AEs

3.9%

Results posted

Mar 2022

Primary outcomePrimary: Best Response as Measured by CT, Bone Scans, and Clinical Progression — 1; 0; 0; 1 Participants

Summary

RATIONALE: Tretinoin may help kidney cancer cells develop into normal cells. Interferon alfa may interfere with the growth of cancer cells. PURPOSE: Phase II trial to study the effectiveness of liposomal tretinoin plus interferon alfa in treating patients who have metastatic kidney cancer.

Outcome Measures

Outcome	Result	p-value
PRIMARY Best Response as Measured by CT, Bone Scans, and Clinical Progression	1; 0; 0; 1; 1; 3	—
PRIMARY Number of Subjects With Toxicity by Clinical Evaluation From First Dose to 30 Days After Last Dose	7; 8; 5; 4; 0; 0	—
SECONDARY Change in Retinoic Acid Receptor Expression on Tissue as Measured by Number of Subjects With the Presence of Peripheral Blood Lymphocytes During the First and Fifth Dose	—	—
SECONDARY Duration of Response (Progression-free Survival) as Measured by CT, Bone Scans, and Clinical Progression From Initiation of Therapy Until an Increase of ≥ 25% From the Smallest Sum of All Tumor Measurements Obtained During the Best Response	5; 7; 4; 3	—

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed metastatic renal cell carcinoma
Bidimensionally measurable disease
No active brain metastases

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Karnofsky 60-100%

Life expectancy:

More than 3 months

Hematopoietic:

WBC at least 3,000/mm^3
Platelet count at least 100,000/mm^3
No coagulation disorders

Hepatic:

Bilirubin less than 1.5 mg/dL
SGOT and SGPT less than 112.5 IU/L each or less than 2.5 times upper limit of normal
No clinically significant hepatic disease, including autoimmune hepatitis

Renal:

Creatinine less than 2 mg/dL OR
Creatinine clearance greater than 50 mL/min
No clinically significant renal disease

Cardiovascular:

No clinically significant cardiac disease
No thrombophlebitis

Pulmonary:

No severe debilitating pulmonary disease
No pulmonary embolism

Other:

No history of diabetes mellitus prone to ketoacidosis
No known hypersensitivity to retinoids or retinoic acid derivatives or to interferon or any component of the injection for this study
No thyroid abnormalities that hinder maintaining thyroid function at the normal range
No severe infection
No severe malnutrition
No clinically significant retinal abnormalities
No pre-existing psychiatric condition, especially depression or a history of severe psychiatric disorder
No other concurrent malignancy except nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use 2 effective methods of contraception during and for 1 month after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No more than 1 prior biological response modifier therapy or immunotherapy

Chemotherapy:

No more than 1 prior chemotherapy regimen

Endocrine therapy:

No concurrent steroids

Radiotherapy:

At least 4 weeks since prior radiotherapy

Surgery:

At least 4 weeks since prior major surgery

Other:

No prior retinoid therapy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00003656). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.