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Monoclonal Antibodies

Bevacizumab + Temsirolimus for Cancer

Phase 1
Waitlist Available
Led By Sarina A Piha-Paul
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Patients should be at least four weeks from the last day of therapeutic radiation or cytotoxic chemotherapy or from antibody therapy, or at least five half-lives from non-cytotoxic targeted or biologic therapy; patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights

Study Summary

This trial is studying the best dose and side effects of bevacizumab and temsirolimus when given alone or with valproic acid or cetuximab to treat patients with a non-cancerous malignancy.

Who is the study for?
This trial is for adults and children with advanced or metastatic cancer, or progressive benign diseases like LAM, NF type 2, Erdheim Chester disease. Participants must be in a certain health condition (Karnofsky >=60%, Lansky status >=60% for under 16s), not pregnant, using contraception, and have specific blood counts and organ function levels. They should not be on other cancer treatments or have had major surgery recently.Check my eligibility
What is being tested?
The study tests the effects of Bevacizumab and Temsirolimus alone or combined with Valproic Acid or Cetuximab on various cancers and benign diseases. It aims to find the safest doses while assessing how these drugs affect tumor growth by altering immune responses or blocking enzymes needed for cell growth.See study design
What are the potential side effects?
Possible side effects include allergic reactions to drug components, increased risk of infection due to immune system changes, potential bleeding issues, high blood pressure risks from Bevacizumab; liver problems from Temsirolimus; skin reactions from Cetuximab; and fatigue or digestive issues from chemotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and perform daily activities.
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I have not had certain cancer treatments for a specific time before joining this trial.
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My advanced cancer hasn't responded to standard treatments, or there are no effective standard treatments available.
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I agree to use effective birth control or abstain from sex during and for 90 days after the study.
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I am mostly able to care for myself but may need occasional help.
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I am 16 or younger and can do most activities.
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I am not currently taking any experimental drugs or other cancer treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MTD of temsirolimus, defined as the dose level below the dose at which 2 of 6 patients experience DLT
Maximum tolerated dose (MTD) of bevacizumab, defined as the dose level below the dose at which 2 of 6 patients experience drug-related dose limiting toxicity (DLT)
Secondary outcome measures
Anti-tumor efficacy of each combination (objective response)
Levels of surrogate anti-angiogenesis markers
Other outcome measures
The properties of the tissue microvasculature.

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358
65%
Infusion related reaction
59%
Neutrophil count decreased
41%
Upper respiratory infection
29%
Aspartate aminotransferase increased
29%
Platelet count decreased
24%
Alanine aminotransferase increased
18%
Sinusitis
18%
Urinary tract infection
12%
Tooth infection
6%
Bronchial infection
6%
Acute Coronary Syndrome
6%
Febrile neutropenia
6%
Sepsis
6%
Infections and infestations - Other, specify
6%
Nail infection
6%
Rhinitis infective
6%
Tumor lysis syndrome
6%
Infusion Related Reaction
6%
Wound infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2 and MTD (800 mg Entospletinib Daily)
Phase 1, Dose 1 (400 mg Entospletinib Daily)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group III (temsirolimus, bevacizumab)Experimental Treatment4 Interventions
Patients receive temsirolimus and bevacizumab as in Group I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Group II (temsirolimus, bevacizumab, valproic acid)Experimental Treatment5 Interventions
Patients receive temsirolimus and bevacizumab as in Group I and valproic acid PO on days 1-7 and 15-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group III: Group I (temsirolimus, bevacizumab, cetuximab)Experimental Treatment5 Interventions
Patients receive temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22; bevacizumab IV over 30-90 minutes on days 1 and 15; and cetuximab IV over 60-120 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Temsirolimus
2008
Completed Phase 2
~1940
Valproic Acid
2006
Completed Phase 4
~1280
Cetuximab
2011
Completed Phase 3
~2480

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,184 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,603 Previous Clinical Trials
40,913,120 Total Patients Enrolled
Sarina A Piha-PaulPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
295 Total Patients Enrolled

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT01552434 — Phase 1
Cancer Research Study Groups: Group III (temsirolimus, bevacizumab), Group II (temsirolimus, bevacizumab, valproic acid), Group I (temsirolimus, bevacizumab, cetuximab)
Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT01552434 — Phase 1
Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01552434 — Phase 1

Frequently Asked Questions

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

What medical issues does Pharmacological Study typically address?

"Pharmacological Study is a beneficial therapeutic approach for organ transplantation, as well as catarrh, psoriasis and advanced non-squamous non-small cell lung cancer."

Answered by AI

Is this research initiative currently opening its doors to participants?

"According to clinicaltrials.gov, the recruitment phase for this trial is closed with the last update being posted on July 18th 2022. However, there are 8579 other studies actively recruiting right now; this study was originally listed as of March 16th 2012."

Answered by AI

What is the participant quota for this clinical trial?

"This clinical study is not currently open for recruitment. Although it was initially posted on March 16th 2012 and edited most recently on July 18 2022, other medical trials are readily enrolling patients with soft tissue neoplasms (7,956) or Pharmacological Studies (623)."

Answered by AI

Has the Pharmacological Study obtained clearance from the FDA?

"Our team at Power assessed the safety of this pharmacological study as a 1 due to its Phase 1 status, signifying sparse clinical data available for both efficacy and safety."

Answered by AI
~0 spots leftby Mar 2024