Brain and Nervous SystemPhase 1NCT00251797
A Phase I Trial Using Combination Irinotecan and Thalidomide for Recurrent CNS Tumors
A Phase 1 study testing Irinotecan and Thalidomide in people with Brain and Nervous System and Cancer, run by University of New Mexico at 1 site in United States.
Trial summary
The study will try to answer these questions: 1. What is the highest dose of thalidomide brain cancer patients can receive safely in combination with irinotecan? 2. How well does this combination work to shrink brain tumors, and how long do responses to treatment last? 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain and Nervous System, Cancer
- What is being tested?
- Irinotecan and Thalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2000to Jun 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven high grade astrocytomas, glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendroglioma, mixed oligodendroglioma.
- Subjects are allowed to have definitive surgery and/or radiation treatment to their tumors.
- Subjects are allowed to have previous chemotherapy for their tumors.
- Subjects who previous diagnosed to have a low grade lesion need a second biopsy to show transformation into a high grade histology.
- Subjects need to have radiographic or biopsy proven recurrent disease.
- ECORT performance status 2 or lower. See appendix I.
Show all 11Show fewer
- Baseline laboratory values within 30 days of study entry: hemoglobin 10 gm/dl; absolute neutrophil count 1,500 cells/ml; platelet counts 100,000 cells/ml; SGOT/AST, SGPT/ALT, alkaline phosphatase, LDH 3high normal limit; total bilirubin 2.0 mg/dl.
- Ability to provide written informed consent.
- Age > 18 years.
- Female patients of childbearing potential must have a documented negative serum pregnancy test within 14 days of study entry.
- All subjects must agree to use an effective method of contraception for the duration of treatment if engaged in sexual activity where conception is possible, as specified in the STEP program for thalidomide.
Who cannot join
- Therapy with any investigational drug (other than drugs available on treatment IND and used for FDA-sanctioned indications) and/or any chemotherapy regimen within 28 days of study entry.
- Prior therapy with either irinotecan or thalidomide.
- Oxygen saturation 90% on room air.
- Cardiac insufficiency at New York Heart Association status 2 or greater.
- Other active malignancies except basal or squamous cell carcinoma of the skin or in situ cervical and breast lesions.
- History of neuropsychiatric disorder or altered mental status which prevent informed consent or compliance with protocol requirement.
- Known hypersensitivity or allergic reaction to study drug.
- Women at any stage of pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
Official title: A Phase I Trial Using Combination Irinotecan and Thalidomide for Recurrent CNS Tumors.
The study will try to answer these questions:
- What is the highest dose of thalidomide brain cancer patients can receive safely in combination with irinotecan?
- How well does this combination work to shrink brain tumors, and how long do responses to treatment last?
- What side effects does the combination of drugs cause?
- How does treatment affect patients' quality of life (how they feel and what activities they are able to do)?
Read the detailed description
This is a Phase I study, which means these trials are generally comparatively small and are used to determine toxicity and maximum dose. Currently, there are no "standard" treatments for Recurrent CNS Tumors. In this study, approximately 14 patients with Recurrent CNS Tumors will receive treatment with irinotecan, an intravenous drug, and thalidomide, a drug taken by mouth. Both have been approved by the Federal Food and Drug Administration as treatments for cancer, but they have not been tested together for brain cancer.
The study will try to answer these questions:
- What is the highest dose of thalidomide brain cancer patients can receive safely in combination with irinotecan?
- How well does this combination work to shrink brain tumors, and how long do responses to treatment last?
- What side effects does the combination of drugs cause?
- How does treatment affect patients' quality of life (how they feel and what activities they are able to do)?
- Conditions
- Brain and Nervous System, Cancer
- Being tested
- Irinotecan, Thalidomide
- Keywords
- Phase I, Brain cancer, Recurrent CNS tumors
- Medical subject headings
- Neurologic Manifestations, Neoplasms, Brain Neoplasms, Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
Also called Camptosar
Irinotecan: 300 to 350 mg/m2 mixing with 250 cc. Dextrose injection. IV infusion over 90 minutes D1 and repeat every 21 days
ThalidomideDrug
Also called Thalomid
Thalidomide 50 mg capsule starting from 4 tablets per day Oral D 3 to D 19 of each cycle
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerable dosage of thalidomide in combination with irinotecan
Measured: Unacceptable toxicities
Secondary outcomes (1)
Tumor response. For this study, the definition of response will include complete response, partial response and stable disease. Duration of tumor response. uality of life while on treatment
Measured: unacceptable toxicities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2005 (estimated)
- Study startMar 2000
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Nervous SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Investigators
- Dennie Jones, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251797
- Sponsor's protocol ID
- 2799C
- Status last verified
- Oct 2008
- First submitted
- 8 Nov 2005
- Last updated
- 7 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial Using Combination Irinotecan and Thalidomide for Recurrent CNS Tumors.
- ClinicalTrials.gov ID
- NCT00251797
- Acronym / sponsor ID
- 2799C
- Conditions
- Brain and Nervous System, Cancer
- Keywords
- Phase I, Brain cancer, Recurrent CNS tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Mar 2000
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 10 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will try to answer these questions:
- What is the highest dose of thalidomide brain cancer patients can receive safely in combination with irinotecan?
- How well does this combination work to shrink brain tumors, and how long do responses to treatment last?
- What side effects does the combination of drugs cause?
- How does treatment affect patients' quality of life (how they feel and what activities they are able to do)?
Detailed description
This is a Phase I study, which means these trials are generally comparatively small and are used to determine toxicity and maximum dose. Currently, there are no "standard" treatments for Recurrent CNS Tumors. In this study, approximately 14 patients with Recurrent CNS Tumors will receive treatment with irinotecan, an intravenous drug, and thalidomide, a drug taken by mouth. Both have been approved by the Federal Food and Drug Administration as treatments for cancer, but they have not been tested together for brain cancer.
The study will try to answer these questions:
- What is the highest dose of thalidomide brain cancer patients can receive safely in combination with irinotecan?
- How well does this combination work to shrink brain tumors, and how long do responses to treatment last?
- What side effects does the combination of drugs cause?
- How does treatment affect patients' quality of life (how they feel and what activities they are able to do)?
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Biopsy proven high grade astrocytomas, glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendroglioma, mixed oligodendroglioma.
- Subjects are allowed to have definitive surgery and/or radiation treatment to their tumors.
- Subjects are allowed to have previous chemotherapy for their tumors.
- Subjects who previous diagnosed to have a low grade lesion need a second biopsy to show transformation into a high grade histology.
- Subjects need to have radiographic or biopsy proven recurrent disease.
Key exclusion criteria (8 listed)
- Therapy with any investigational drug (other than drugs available on treatment IND and used for FDA-sanctioned indications) and/or any chemotherapy regimen within 28 days of study entry.
- Prior therapy with either irinotecan or thalidomide.
- Oxygen saturation 90% on room air.
- Cardiac insufficiency at New York Heart Association status 2 or greater.
- Other active malignancies except basal or squamous cell carcinoma of the skin or in situ cervical and breast lesions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IrinotecanAlso: CamptosarIrinotecan: 300 to 350 mg/m2 mixing with 250 cc. Dextrose injection. IV infusion over 90 minutes D1 and repeat every 21 days | Drug | – |
| ThalidomideAlso: ThalomidThalidomide 50 mg capsule starting from 4 tablets per day Oral D 3 to D 19 of each cycle | Drug | – |
Primary outcome
Tolerable dosage of thalidomide in combination with irinotecan
Time frame: Unacceptable toxicities
1 secondary outcome
Tumor response. For this study, the definition of response will include complete response, partial response and stable disease. Duration of tumor response. uality of life while on treatment
Time frame: unacceptable toxicities
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2010.
Related trials for Brain and Nervous System
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Recruiting
Dietary Intervention for Migraine Relief
Migraine
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
Not yet recruitingPhase 1/2
4SCAR-T Therapy Targeting GD2, PSMA and CD276 for Treating Neuroblastoma
Neuroblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennie Jones, MD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Irinotecan and Thalidomide in people with Brain and Nervous System and Cancer, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerable dosage of thalidomide in combination with irinotecan (time frame: Unacceptable toxicities). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2010.