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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

Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose

Must not have

Colorectal cancer patients with known v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation (for the arm combining bevacizumab, temsirolimus and cetuximab)

Uncontrolled systemic vascular hypertension (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg on medication)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My colorectal cancer has a KRAS mutation.

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My blood pressure is controlled and below 140/90 mmHg on medication.

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I have not had any unexplained bleeding in the last 28 days.

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I haven't had a stroke, heart attack, or unstable chest pain in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Anti-tumor efficacy of each combination (objective response)

Levels of surrogate anti-angiogenesis markers

Other study objectives

The properties of the tissue microvasculature.

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358

33%

Infusion Related Reaction

33%

Alanine aminotransferase increased

33%

Aspartate aminotransferase increased

33%

Neutrophil count decreased

17%

Sinusitis

17%

Tumor Lysis Syndrome

17%

Interoperative Hemorrhage

17%

Platelet count decreased

17%

Febrile neutropenia

17%

Infusion related reaction

17%

Upper respiratory infection

17%

Otitis externa

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1, Dose 1 (400 mg Entospletinib Daily)

Phase 2 and MTD (800 mg Entospletinib Daily)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~5540

Temsirolimus

2008

Completed Phase 2

~1940