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COMPLETEDPHASE1

Ridaforolimus and Vorinostat in Treating Patients With Advanced Solid Tumors or Lymphoma

A Phase I Study of Ridaforolimus and Vorinostat in Patients With Advanced Solid Tumors or Lymphoma (IND 109130)

NCT01169532•Fox Chase Cancer Center

Summary

This phase I trial is studying the side effects and best dose of giving ridaforolimus and vorinostat together in treating patients with advanced solid tumors or lymphoma. Giving ridaforolimus in combination with vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed Description

PRIMARY OBJECTIVES: I. To determine which dose combinations of Ridaforolimus and Vorinostat are safe and tolerable. II. To define the maximum tolerated dose. III. To characterize dose limiting toxicities. SECONDARY OBJECTIVES: I. To describe the activity of this combination amongst all enrolled patients in terms of response rate, progression free survival and overall survival. II. To describe the activity of this combination in the subset of patients with RCC in terms of response rate, progression free survival and overall survival. III. To describe the pharmacodynamic effects of these agents in combination. OUTLINE: This is a dose escalation study. Patients receive ridaforolimus orally (PO) once daily on days 1-5 and vorinostat PO twice daily on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every three months for up to 3 years.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histological or cytological confirmation of a solid, malignant tumor or lymphoma that is refractory to standard therapies or for which no standard therapies exist
•Patients must have received at least one prior systemic therapy
•Measureable disease by RECIST v 1.1
•ECOG PS 0 or 1
•ANC \>= 1500/uL
•Hgb \>= 9 g/dL
•Platelets \>= 100,000/uL
•AST/SGOT and ALT/SGPT =\< 2.5 x upper limit of normal (ULN) or =\< 5.0 x ULN in patients with liver metastases
•Total Bilirubin =\< 1.5 times ULN
•Creatinine =\< 2.0 mg/dL or Creatinine Clearance (calculated or 24 hour urine) \>= 50 ml/min
+6 more criteria

Exclusion Criteria

•Prior anti-cancer treatment with either an mTOR inhibitor (i.e. temsirolimus, everolimus), or an HDAC inhibitor (i.e. Vorinostat)
•Patients who have received bevacizumab =\< 6 weeks prior to day 1 of study treatment; patients who have received other chemotherapy, immunotherapy, or radiotherapy =\< 3 weeks prior to day 1 of study treatment or those who have not recovered from acute adverse events due to agents administered \>= 3 weeks earlier; for patients receiving targeted therapy, treatment must be discontinued at least five half-lives prior to initiation of day 1 of study treatment
•Patients who have taken valproic acid =\< 2 weeks of study enrollment; valproic acid is another HDAC inhibitor
•Patients who are pregnant, plan to become pregnant, or are breastfeeding
•History of gastrointestinal bleeding within1 month of enrollment
•Serum cholesterol \>= 350 mg/dL or serum triglycerides \>= 400 mg/d
•Poorly controlled Type 1 or 2 diabetes, defined as hemoglobin A1C greater than 8% or a fasting glucose of \> 160 mg/dL
•Active infection requiring antibiotics
•Anaphylactic reaction to macrolide antibiotics, Tween 80 (polysorbate 80)
•Patients who are not adequately recovered from a prior surgical procedure or major surgical procedure within 2 weeks prior to the first dose of study drug
+2 more criteria

Locations (1)

Fox Chase Cancer Center

Rockledge, Pennsylvania, United States

Key Dates

Start Date

October 1, 2010

Primary Completion Date

March 1, 2014

Completion Date

March 1, 2014

Last Updated

February 21, 2021

Enrollment

ACTUAL participants

Conditions

LymphomaUnspecified Adult Solid Tumor, Protocol Specific

Interventions

ridaforolimus

DRUG

vorinostat

DRUG

biopsy

PROCEDURE

pharmacological study

OTHER

laboratory biomarker analysis

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 21, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Ridaforolimus and Vorinostat in Treating Patients With Advanced Solid Tumors or Lymphoma

Inclusion Criteria

Exclusion Criteria

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