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Anti-tumor antibiotic, Anti-metabolites

Chemotherapy + Biological Therapy for Kidney Cancer

Phase 2

Waitlist Available

Research Sponsored by Cancer Biotherapy Research Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hepatic: Bilirubin less than 2.0 mg/dL, SGOT no greater than 1.25 times ULN (unless due to tumor)

Performance status: ECOG 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying how well giving combination chemotherapy with interleukin-2 and interferon alfa together works in treating patients with kidney cancer.

Who is the study for?

This trial is for adults aged 18-70 with kidney cancer that has spread or can't be surgically removed. They should have a life expectancy over 4 months, adequate blood counts, and normal liver function. Pregnant or nursing individuals are excluded, as well as those with certain other health conditions like severe diarrhea, recent heart attacks, or uncontrolled heart disease.Check my eligibility

What is being tested?

The study is testing the effectiveness of combining chemotherapy drugs with biological therapies (Interleukin-2 and Interferon alfa) to treat metastatic or inoperable kidney cancer. It's a Phase II trial aiming to see if this combination helps more than standard treatments.See study design

What are the potential side effects?

Potential side effects may include reactions from the immune system such as flu-like symptoms, fatigue, changes in blood pressure; digestive issues; skin reactions; and an increased risk of infections due to white blood cell alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver function tests are within normal limits, except for cancer-related issues.

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I am able to get out of my bed or chair and move around.

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My kidney cancer cannot be removed by surgery.

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My heart condition is stable with no recent severe issues.

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I am between 18 and 70 years old.

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My kidney tests for creatinine and calcium are within normal limits, and I have minimal protein in my urine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cancer Biotherapy Research GroupLead Sponsor

12 Previous Clinical Trials

90 Total Patients Enrolled

Gamini S. Soori, MD, FACP, FRCP, MBAStudy ChairCancer Biotherapy Research Group

Media Library

Combination Chemotherapy (Anti-tumor antibiotic, Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00003664 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment process for this research project open to participants over 80 years old?

"This trial is open to individuals who are within the age range of 18-70 years."

Answered by AI

Who is able to enter this research protocol?

"To qualify for this research project, candidates must have been diagnosed with carcinoma or renal cell and be between the age of majority and 70 years old. As of now, roughly 30 people are eligible to join."

Answered by AI

What potential implications could this treatment have on the health of individuals?

"Our team at Power assigned a 2 out of 3 rating to the safety profile of this treatment due to existing evidence that supports its security, but none indicating it is efficacious."

Answered by AI

Is enrollment in this medical experiment open to the public?

"This investigation is not currently open to enrolment, as per information presented on clinicaltrials.gov; the trial was initially posted in October 1998 and its most recent update occurred in November 2013. Despite this fact, there are 423 other medical trials actively seeking candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combination Chemotherapy and Biological Therapy In Treating Patients With Kidney Cancer That Is Metastatic or Cannot Be Removed Surgically

1998. "Combination Chemotherapy and Biological Therapy In Treating Patients With Kidney Cancer That Is Metastatic or Cannot Be Removed Surgically". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00003664.

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