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Repeat Radiation, Minocycline and Bevacizumab in Patients With Recurrent Glioma (RAMBO)

This study is currently recruiting participants.
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Verified August 2016 by University of Utah
Information provided by (Responsible Party):
University of Utah Identifier:
First received: March 6, 2012
Last updated: August 16, 2016
Last verified: August 2016
The primary objective of step 1 is the rate of adverse events of minocycline and bevacizumab during reirradiation and of step 2 is the response rate to bevacizumab, reirradiation, and minocycline. The secondary objectives are the response rate, PFS-3, PFS-6, and effects on quality of life and cognition from repeat radiation and bevacizumab.

Condition Intervention Phase
Recurrent Glioma Drug: Bevacizumab Drug: Minocycline Radiation: Radiation Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1b/2 Study of Repeat rAdiation, Minocycline, and Bevacizumab in Patients With Recurrent gliOma (RAMBO)

Resource links provided by NLM:

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Rate of Adverse Events [ Time Frame: 30 months ]
    Rate of adverse events of minocycline and bevacizumab during reirradiation

  • Response rate [ Time Frame: 30 months ]
    Response rate to bevacizumab, reirradiation, and minocycline

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 30 months ]
    Effects on quality of life from repeat radiation and bevacizumab

  • Cognitive effects [ Time Frame: 30 months ]
    Effects on cognition from repeat radiation and bevacizumab

Estimated Enrollment: 18
Study Start Date: July 2012
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All patients
All patients enrolled in study.
Drug: Bevacizumab
This is an open-label, multi-agent design. Bevacizumab will be administered in accordance with the FDA-approved dose for gliomas, 10mg/kg IV every 2 weeks. Bevacizumab will be continued every two weeks as long as tolerated. One cycle of bevacizumab will be 28 days, with treatments on day1 and day 15. Blood pressure, CBC, CMP, and urine protein level, either by UA or urine protein/creatinine ratio will be checked at the beginning of each cycle.
Other Name: Avastin
Drug: Minocycline
Minocycline will be given by mouth twice a day starting at about half of the monotherapy maximal tolerated dose, 100 mg PO BID. Minocycline will be started on the day prior to radiation and continued until progression or intolerance. During the combined radiation, minocycline, and bevacizumab treatment, patients will be seen weekly with a CBC, CMP, and adverse event monitoring.
Radiation: Radiation
Radiation planning will be individualized by the radiation oncologist based on the location of the current radiation field relative to prior radiation doses. The length and fractionation will be determined individually by the radiation oncologist.

Detailed Description:

After providing informed consent, patients will undergo screening for eligibility to participate in the study. Screening will start within 21 days prior to dosing.

Subjects will have an MRI within 21 days of starting radiation. QOL and cognition measures will be performed within 21 days of starting radiation. Radiation will be given with parameters determined on an individual basis by the radiation oncologist. Bevacizumab will be continued at 10mg/kg IV every 2 weeks. Minocycline will be given twice a day starting at 100mg PO BID. MRI, QOL, and cognitive tests will be obtained 1, 3 and 6 months after the end of radiation.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female patients ≥18 years old with a life expectancy of at least 8 weeks
  2. Radiographically proven recurrent (≥ first relapse), intracranial glioma
  3. Previous treatment with external beam radiation
  4. Radiographic progression on current or prior bevacizumab treatment
  5. Women of child-bearing potential must have a negative pregnancy test within 7 days of initiation of dosing and must agree to use an acceptable method of birth control while on study drug and for 3 months after the last dose. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year. Men of child-bearing potential must also agree to use an acceptable method of birth control while on study drug, and for 3 months after the last dose.
  6. Karnofsky performance status of ≥50
  7. Adequate hematologic, hepatic, and renal function (absolute neutrophil count ≥1.0 x 109/L, Hgb >9 g/dL, platelet count ≥50 x 109/L, AST/ALT ≤2.5x ULN, creatinine ≤1.5x ULN)
  8. Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements
  9. Systolic blood pressure ≤ 160 mg Hg or diastolic pressure ≤ 90 mg Hg within 14 days prior to study registration
  10. Prothrombin time/international normalized ratio (PT INR) < 1.4 for patients not on warfarin confirmed by testing within 14 days prior to study registration
  11. Patients on full-dose anticoagulants (e.g., warfarin or LMW heparin) must have no active bleeding or pathological condition that carries a high risk of bleeding, and must be on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin

Exclusion Criteria:

  1. Use of an investigational drug within 14 days or within 5 half-lives of teh investigational drug, whichever is shorter
  2. Progression within 3 months of previous radiation by RANO criteria
  3. History of Grade 2 (CTCAE v4) or greater acute intracranial hemorrhage
  4. A concurrent active cancer that requires non-surgical therapy (e.g. chemotherapy, radiation, adjuvant therapy).
  5. Patients with serious illnesses, uncontrolled infection, medical conditions, or other medical history including abnormal laboratory results, which in the investigator's opinion would be likely to interfere with a patient's participation in the study, or with the interpretation of the results
  6. Women of child-bearing potential who are pregnant or breast feeding
  7. Unstable angina and/or congestive heart failure in the last 6 months, transmural myocardial infarction within the last 6 months, New York Heart Association grade II or higher congestive heart failure requiring hospitalization within 12 months prior to registration, evidence of recent myocardial infarction by EKG performed within 14 days of registration, serious or inadequately controlled cardiac arrhythmia, significant vascular and peripheral vascular disease, evidence of bleeding diathesis or coagulopathy
  8. History of stroke, cerebral vascular accident (CVA) or transient ischemic attack within 6 months
  9. Serious or non-healing wound, ulcer, or bone fracture or history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration, with the exception of the craniotomy for tumor resection
  10. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  11. Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01580969

Contact: Britney Hall 801-213-4323
Contact: Amiee Maxwell 801-587-5562

United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
  More Information

Responsible Party: University of Utah Identifier: NCT01580969     History of Changes
Other Study ID Numbers: HCI55264
Study First Received: March 6, 2012
Last Updated: August 16, 2016

Keywords provided by University of Utah:

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Bacterial Agents
Anti-Infective Agents processed this record on July 21, 2017