Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Carcinoma, Renal Cell

Kidney Neoplasms

Carcinoma

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Antineoplastic Agents

Analgesics

All Drugs and Chemicals

Interleukin-2

Analgesics, Non-Narcotic

Walter Quan, MD

The purpose of this study is to determine whether Interleukin-2 at the dose and schedule used in this study will help increase tumor shrinkage.

In this phase II study, the IL-2 schedule (daily IL-2 for 5 days (per week) every 3 weeks) will be tested in a cohort of kidney cancer patients to attempt to determine the response rate, median duration of response, and median survival. The dose intensity of this schedule would allow a patient treated on this regimen to achieve the target threshold (\> 1440 million IU/m2/year).

Interleukin-2 in Metastatic Kidney Cancer

Phase II Trial of Moderate Dose Bolus Interleukin-2 in Metastatic Kidney Cancer

Radiographic studies to evaluate for response were done after every 2 cycles (6 weeks) until disease progression or death from any cause up to 2 years. Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = 100%(CR + PR/total number of patients receiving Interleukin-2).

Duration of response is calculated as the time (months) from the date at which response is first observed (per standard Response Evaluation Criteria In Solid Tumors \[RECIST\] to the date of first observed disease progression or date of death from any cause, whichever came first, assessed up to 2 years. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.

Western Regional Medical Center

Adverse Events

Number of Participants

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Jessica L. Coats

Percentage of Patients Responding to Interleukin-2

Response Rate

Number of Participants With Response Using RECIST Criteria

There are no data recordings for this study. The study was terminated and the investigator is no longer related to the site. There is no additional information to provide.

Median Duration of Response

Median Survival

Interleukin 2 (IL-2) is naturally produced by the body to help fight infection and prevent autoimmune diseases. In cancer treatment, IL-2 is designed to target adaptive immune cells, such as T-cells and B-cells, to respond to tumors. IL-2 may help the body produce antigen-fighting T-cells and stimulate B-cells to produce more antibodies.

Overall Study

Clear Cell Renal Cell Carcinoma

Micronutrients

Natriuretic Agents

Hematinics

Pharmaceutical Solutions

Dermatologic Agents

Immune Checkpoint Inhibitors

Iron

Olaparib

Mannitol

Ferrosoferric Oxide

Silicon

Titanium dioxide

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Participants with metastatic renal cell carcinoma that harbor an inactivating mutation in BAP-1, ATM, BRCA1, BRCA2, PALB2, CHEK2, BRIP1, RAD51C, BARD1, CDK12, CHEK1, FANCL, PP2R2A, RAD51B, RAD51D, or RAD54L that have had prior treatment with at least one immune checkpoint inhibitor or anti-VEGF therapy with measureable disease on CT imaging according to RECIST 1.1 criteria. Participants will be initially treated with olaparib 150mg by mouth twice daily for one month. After one month of therapy, the dose will be increased to 300mg by mouth twice daily provided there are no grade 3 or greater adverse events experienced. Reassessment will occur at least monthly for toxicity. Radiological scans will be performed every 3 months to assess disease response. Treatment will be continued until clinical and/or radiographic progression according to RECIST 1.1 criteria or unmanageable toxicity requiring cessation.

Olaparib is a crystalline solid, is non-chiral and shows pH-independent solubility of approximately 0.1 mg/mL across the physiological range. Olaparib is presented for oral administration as a green, film-coated tablet containing 25 mg, 100 mg or 150 mg of drug substance. The 100 mg strength is also available as a yellow, film-coated tablet. The 25 mg, 100 mg and 150 mg strengths of olaparib tablets are composed of the same constituents. The tablet cores comprise: olaparib, copovidone, colloidal silicon dioxide, mannitol and sodium stearyl fumarate. The composition of the green tablet film coating is: hydroxypropyl methylcellulose (hypromellose), macrogol 400 (polyethylene glycol 400), titanium dioxide, iron oxide yellow and iron oxide black. The yellow tablet film coating only differs from the green film coating with the omission of iron oxide black.

Irina Rifkind, RN, MSN

Rana Sullivan, RN, BSN

Irina Rifkind, RN/MSN

Mark Markowski, MD/PhD

Mark C Markowski, MD, Ph.D

Single arm, single site, open-label Phase II study of the effects of oral olaparib in participants with metastatic renal cell carcinoma that harbor an inactivating mutation in BAP-1, ATM, BRCA1, BRCA2, PALB2, CHEK2, BRIP1, RAD51C, BARD1, CDK12, CHEK1, FANCL, PP2R2A, RAD51B, RAD51D, or RAD54L who have had prior treatment with at least one immune checkpoint inhibitor or anti-VEGF therapy. Must have measurable disease on CT imaging per RECIST 1.1 criteria.

The trial will enroll up to 20 participants. Following enrollment, participants will be initially treated with olaparib 150mg by mouth twice daily for one month. After one month of therapy, the dose of olaparib will be increased to 300mg by mouth twice daily provided there are no grade 3 or greater adverse events experienced. All participants will be reassessed at least monthly for toxicity, including laboratory investigations. Radiological scans will be performed approximately every 3 months to assess for disease response. Treatment will be continued until clinical and/or radiographic progression according to RECIST 1.1 criteria or unmanageable toxicity requiring cessation.

Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations

Phase II Study of Olaparib in Metastatic Renal Cell Carcinoma Patients Harboring a BAP-1 or Other DNA Repair Gene Mutations (ORCHID)

Number of incidences of reversion mutations in circulating tumor DNA (ctDNA) at time of clinical progression.

Complete response (CR) or partial response (PR) at any time on study or stable disease (SD) after 6 months of Olaparib treatment, based on RECIST 1.1 criteria.

Number of Adverse Events, Grade 3 or higher as defined by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Number of months from the time of initiation on Olaparib therapy until radiographic progression or death, whichever comes first while enrolled on the study, based on RECIST 1.1 criteria.

Number of participants with best overall response (complete response (CR) or partial response (PR)) at anytime on study.

AstraZeneca

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Interleukin-2 in Metastatic Kidney Cancer	NCT01702909	Renal Cell Canc... Kidney Cancer M...	Interleukin-2	18 Years -	Western Regional Medical Center
Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations	NCT03786796	Renal Cell Carc... Metastatic Rena... Kidney Cancer Renal Carcinoma Kidney Cancer M...	Olaparib	18 Years - 120 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations	NCT03786796	Renal Cell Carc... Metastatic Rena... Kidney Cancer Renal Carcinoma Kidney Cancer M...	Olaparib	18 Years - 120 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Spots Global Cancer Trial Database for kidney cancer metastatic