Clinical Trials > Clinical
Trials of Interest > First Line, Low Toxic
Last update: 03/08/2008
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First
Line Low Toxic | First
Line Primary Therapy | Relapsed / refractory
| Addressing
other unmet needs
First line Low Toxic (with minimal
toxicity)
"First line" means as
first therapy
Goal: Managing indolent lymphomas with minimal toxicity;
maintaining future treatment options.
Also
see Locating
First
Line
Therapies for Lymphoma
 | New:
*
Condition:
B-cell lymphomas, including CLL
Rationale
and goal: "Drugs
used in chemotherapy, such as fenretinide, work in different ways
to stop the growth of cancer cells, either by killing the cells or
by stopping them from dividing. Monoclonal antibodies, such as
rituximab, can block cancer growth in different ways. Some find
cancer cells and kill them or carry cancer-killing substances to
them. Others interfere with the ability of cancer cells to grow
and spread. Giving fenretinide together with rituximab may kill
more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and
best dose of fenretinide and to see how well it works when given
together with rituximab in treating patients with B-cell
non-Hodgkin's lymphoma."
* Fenretinide (4-HPR) is a retinoid (vitamin A) analogue with
antitumor and chemopreventive activities. In a mouse model,
Fenretinide showed synergy with Rituxan.
TOPIC SEARCH
Mechanisms - PubMed
TOPIC SEARCH Outcome data - Medscape |
PubMed
TOPIC SEARCH
Safety or Toxicity - PubMed
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| Rituxan followed by Maintenance
(regularly scheduled) Rituxan
Condition: previously untreated stage III or IV NHL with low tumor
burden.
Rationale and goal:
(1) manage
lymphoma with fewer side effects with an immune-based
therapy that
is considered less toxic than chemotherapy and might be less
likely than chemotherapy to preclude future treatment options;
(2) compare different maintenance
schedules of Rituxan to see which, if any, provide a clinical advantage;
(3) identify biological
markers that may predict who is most likely to benefit optimally from Rituxan.
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TOPIC SEARCH Mechanisms - PubMed
TOPIC SEARCH Outcome data - Medscape |
PubMed
TOPIC SEARCH
Toxicity - Medscape
| PubMed
| Enzastaurin
Condition: Previously untreated
follicular NHL in
watchful waiting status
Rationale
and goal: To evaluate the antitumor
activity, as measured by tumor response rate, of enzastaurin in
patients with Follicular Lymphoma..
TOPIC SEARCH
Mechanisms - PubMed
TOPIC SEARCH Outcome data - Medscape |
PubMed
TOPIC SEARCH
Safety or Toxicity - PubMed
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Orally administered protein kinase C-beta (PKCbeta) inhibitor
Source
Also see NEWS: http://www.docguide.com/news/
| Idiotype
vaccine administered with GM-CSF- Genitope.com
Condition: Previously untreated patients with CLL in
watchful waiting status
Rationale
and goal: The treatment being investigated is rId-KLH,
a patient- and tumor-specific therapy known as a personalized
immunotherapy. Personalized immunotherapy uses a person’s own
immune system in an attempt to combat disease. Sargramostim
(a.k.a. GM-CSF) is given together with the personalized
immunotherapy because it may enhance the effect.
TOPIC SEARCH
Mechanisms - PubMed
TOPIC SEARCH Outcome data - Medscape |
PubMed
TOPIC SEARCH
Safety or Toxicity - | PubMed
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| Rituxan
and Denileukin Diftitox
Condition: Previously untreated Stage III or IV Follicular NHL
Rationale and goal: Monoclonal antibodies, such as Rituxan, can block cancer
growth in different ways. Some block the ability of cancer cells
to grow and spread. Others find cancer cells and help kill them or
carry cancer-killing substances to them.
Combinations of
biological substances in denileukin diftitox may be able to carry
cancer-killing substances directly to cancer cells. Giving
rituximab together with denileukin diftitox may kill more cancer
cells.
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Biaxin-Based Antibiotic
Condition: Untreated advanced stage indolent Lymphoma
Rationale and goal: ... to see if a treatment with Biaxin
(clarithromycin) which is an antibiotic given by mouth for 3
months can delay the growth of your lymphoma or shrink the
lymphoma. We would also like to see how Biaxin (clarithromycin)
works on lymphoma and blood cells. There is some evidence that this
medication may change the behavior of lymphocytes, in addition to
its known anti-infection activity.
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Addressing Other Unmet Needs:
TYPE: None-Interventional
Genomic and
Biobank | Outcomes and Toxicities | Quality
of Life | Screening Tests and Imaging
TOPIC SEARCH: Queries of ClinicalTrials.gov for Lymphoma
(none interventional types)
Genomic and Biobank
Studies
| Genome
Expression Study (highly recommended when it's time for a
biopsy)
Rationale: The observed variability in the clinical course of
follicular lymphoma, along with the diverse range of therapeutic
options available, necessitates accurate prognostic stratification
of the individual patient.
Conditions: Lymphoma; Leukemia; Multiple Myeloma; Lymphoid
Malignancies
Locations:
Nebraska Medical Center in Omaha,
Southwest Oncology Group centers- see for centers http://www.swog.org/
the British Columbia Cancer Agency in Vancouver,
Canada;
the Norwegian Radium Hospital in Oslo, Norway;
the University of Würzburg in Würzburg,
Germany;
the University of Barcelona in Barcelona, Spain;
and
St. Bartholomew's Hospital in London, England.
Background: NCI investigators are working with researchers at
the University of Nebraska Medical Center in Omaha to define the
gene expression profiles of all types of human lymphoid
malignancies.
The project is supported by an international collaboration
... The LLMPP uses "Lymphochip" cDNA
(complementary DNA) microarrays, which are enriched in genes that
are expressed in and/or function in lymphocytes. Lymphochip
microarrays allow measurement of the RNA expression levels of the
represented genes. Gene expression profiles developed as a result
of this project may someday be used for disease classification
(diagnosis), prognosis, and therapy selection. Already, results
from the LLMPP indicate that these profiles can improve diagnostic
accuracy and provide prognostic information.
The LLMPP is initiating a multicenter clinical trial to evaluate a
lymphoma diagnostic chip, called LymphDX, which was designed by
the company Affymetrix in collaboration with NCI researchers using
LLMPP data. The study will demonstrate the feasibility of
disseminating the LymphDX microarray technology to all of the
participating sites and will also evaluate the diagnostic utility
of the LymphDX chip in a prospective study.
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Outcomes and
Toxicities
Quality of Life
Screening Tests and
Imaging
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