deltatrials
Active Not Recruiting INTERVENTIONAL NCT01552434

Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease

A Phase I Trial of Bevacizumab, Temsirolimus Alone and in Combination With Valproic Acid, or Cetuximab in Patients With Advanced Malignancy and Other Indications

Sponsor: M.D. Anderson Cancer Center

Updated 19 times since 2017 Last updated: Apr 21, 2026 Started: Oct 16, 2012 Primary completion: Oct 31, 2026 Completion: Oct 31, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Advanced Malignant Neoplasm and Castleman Disease and is currently ongoing. M.D. Anderson Cancer Center leads this study, which shows 19 recorded versions since 2012 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

PRIMARY OBJECTIVES: I. To determine the maximum tolerated doses (MTDs) and dose-limiting toxicities (DLTs) of treatment with bevacizumab and temsirolimus in combination and plus valproic acid or cetuximab. SECONDARY OBJECTIVES: I. Preliminary descriptive assessment of anti-tumor efficacy of each combination. II. Preliminary assessment of the pharmacokinetic, pharmacodynamic markers of target inhibition and correlates of response (optional). OUTLINE: This is a dose-escalation study of bevacizumab and temsirolimus. Patients are assigned to 1 of 3 treatment groups. GROUP I: Patients receive temsirolimus intravenously (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 1-2 hours on days 1, 8, 15, and 22. GROUP II: Patients receive temsirolimus and bevacizumab as in Group I and valproic acid orally (PO) daily on days 1-7 and 15-21. GROUP III: Patients receive temsirolimus and bevacizumab as in Group I. In all groups, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated doses (MTDs) and dose-limiting toxicities (DLTs) of treatment with bevacizumab and temsirolimus in combination and plus valproic acid or cetuximab.

SECONDARY OBJECTIVES:

I. Preliminary descriptive assessment of anti-tumor efficacy of each combination.

II. Preliminary assessment of the pharmacokinetic, pharmacodynamic markers of target inhibition and correlates of response (optional).

OUTLINE: This is a dose-escalation study of bevacizumab and temsirolimus. Patients are assigned to 1 of 3 treatment groups.

GROUP I: Patients receive temsirolimus intravenously (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 1-2 hours on days 1, 8, 15, and 22.

GROUP II: Patients receive temsirolimus and bevacizumab as in Group I and valproic acid orally (PO) daily on days 1-7 and 15-21.

GROUP III: Patients receive temsirolimus and bevacizumab as in Group I.

In all groups, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Apr 2017 · 59 days · monthly snapshot~Apr 2017 – ~Jun 2018 · 14 months · monthly snapshot~Jun 2018 – ~Oct 2018 · 4 months · monthly snapshot~Oct 2018 – ~Oct 2019 · 12 months · monthly snapshot~Oct 2019 – ~Jan 2021 · 15 months · monthly snapshot~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshot~Oct 2021 – ~Feb 2022 · 4 months · monthly snapshot~Feb 2022 – ~Sep 2022 · 7 months · monthly snapshot~Sep 2022 – ~Jul 2023 · 10 months · monthly snapshot~Jul 2023 – ~Oct 2023 · 3 months · monthly snapshot~Oct 2023 – ~May 2024 · 7 months · monthly snapshot~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – ~May 2025 · 6 months · monthly snapshot~May 2025 – ~Nov 2025 · 6 months · monthly snapshot~Nov 2025 – ~Apr 2026 · 6 months · monthly snapshotApr 28, 2026 – present · 2 months · daily API

Change History

19 versions recorded
  1. Apr 28, 2026 — Present [daily]

    Active Not Recruiting

    Phase: PHASE1None

  2. Nov 2025 — Apr 2026 [monthly]

    Active Not Recruiting PHASE1

  3. May 2025 — Nov 2025 [monthly]

    Active Not Recruiting PHASE1

  4. Nov 2024 — May 2025 [monthly]

    Active Not Recruiting PHASE1

  5. Sep 2024 — Nov 2024 [monthly]

    Active Not Recruiting PHASE1

Show 14 earlier versions
  1. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1

  2. May 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE1

  3. Oct 2023 — May 2024 [monthly]

    Active Not Recruiting PHASE1

  4. Jul 2023 — Oct 2023 [monthly]

    Active Not Recruiting PHASE1

  5. Sep 2022 — Jul 2023 [monthly]

    Active Not Recruiting PHASE1

  6. Feb 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE1

    Status: Unknown StatusActive Not Recruiting

  7. Oct 2021 — Feb 2022 [monthly]

    Unknown Status PHASE1

    Status: RecruitingUnknown Status

  8. Jan 2021 — Oct 2021 [monthly]

    Recruiting PHASE1

  9. Oct 2019 — Jan 2021 [monthly]

    Recruiting PHASE1

  10. Oct 2018 — Oct 2019 [monthly]

    Recruiting PHASE1

  11. Jun 2018 — Oct 2018 [monthly]

    Recruiting PHASE1

  12. Apr 2017 — Jun 2018 [monthly]

    Recruiting PHASE1

  13. Feb 2017 — Apr 2017 [monthly]

    Recruiting PHASE1

  14. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE1

    First recorded

Oct 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

This phase I trial studies the side effects and best dose of bevacizumab and temsirolimus alone or in combination with valproic acid or cetuximab in treating patients with a malignancy that has spread to other places in the body or other disease that is not cancerous. Immunotherapy with bevacizumab and cetuximab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as valproic acid, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether bevacizumab and temsirolimus work better when given alone or with valproic acid or cetuximab in treating patients with a malignancy or other disease that is not cancerous.

Contact Information

Sponsor contact:
  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations