|
|
View Clinical Trial (Medical Research Study)
|
A Phase 1 Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies - NCT00741871-77030 (Clinical Trial 238996)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy238996.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Houston |
|
State:
|
|
TX |
| Zip Code: |
|
77030 |
| Conditions: |
|
Lymphoma, Malignant - Hodgkin's Lymphoma - B Cell Lymphoma |
| Purpose: |
|
This is a Phase 1 dose escalation study to determine the maximum tolerated dose and the dose
limiting toxicities of SB1518 when given alone once daily by mouth to subjects with advanced
lymphoid malignancies.
|
| Study summary: |
|
|
| Criteria: |
|
Inclusion Criteria:
- Subjects with histologically documented diagnosis of a lymphoid malignancy as defined
in the World Health Organization (WHO) classification scheme except for those listed
in Exclusion Criteria
- Subject must have received at least 2 prior regimens for their lymphoid malignancy,
one of which was an anthracycline-containing combination regimen and have shown
disease relapse or did not respond to the prior regimen
- Subjects with classic HL or diffuse large B cell lymphoma must have failed, refused
or are ineligible to receive stem cell transplant
- Subjects must have measurable lesions (at least one target lesion measuring 2cm in
diameter) by computerized tomography (CT) scan
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- All men of reproductive potential and women of child-bearing potential must agree to
practice effective contraception during the entire study period and for one month
after the last study treatment unless documentation of infertility exists.
Additionally, women of child-bearing potential must have a negative pregnancy test
within 14 days prior to the first dose of study drug
- Able to understand and willing to sign the informed consent form
Exclusion Criteria:
- Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like
lymphoma, lymphoblastic lymphoma/leukemia, multiple myeloma, or HIV-associated
lymphoma
- History of or active Central Nervous System (CNS) malignancy
- Has undergone allogeneic stem cell transplant and were treated with immunosuppressing
agent within the past 6 months
- Active Graft-versus-host disease (GVHD)
- Uncontrolled inter-current illness including, but not limited to, ongoing active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements as judged by treating physician. Subjects receiving antibiotics
for infections that are under control may be included in the study
- Concurrent malignancy, except those subjects with early stage squamous cell carcinoma
of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia
are eligible for the study
- Known HIV-positive (such subjects are at increased risk of lethal infections when
treated with potentially marrow-suppressive therapy)
- Known active Hepatitis A, B or C
- Women who are pregnant or lactating |
|
|
|
| Study is available at: |
|
MD Anderson Cancer Center
Houston, TX 77030
United States
Primary Contact:
Amanda Copeland, MSN, CNS
Email: ARCopeland@mdanderson.org
Phone: 713-792-9455 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
November 16, 2009 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|
|
|
|