THIOTEPA FOR INJECTION USP
Thiotepa for Injection USP is an ethylenimine-type compound. It is supplied as a non-pyrogenic, sterile Iyophilized powder for intravenous, intracavitary or intravesical administration, containing 15 mg of thiotepa. Thiotepa is a synthetic product with antitumor activity.
Thiotepa (thiotepa INTRACAVITARY) is indicated for the following:
Thiotepa has been tried with varying results in the palliation of a wide variety of neoplastic diseases. However, the most consistent results have been seen in the following tumors:
- Adenocarcinoma of the breast.
- Adenocarcinoma of the ovary.
- For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities.
- For the treatment of superficial papillary carcinoma of the urinary bladder.
While now largely superseded by other treatments, thiotepa has been effective against other lymphomas, such as lymphosarcoma and Hodgkin's disease.
Published Studies Related to Thiotepa (Thiotepa Intracavitary)
[Randomized clinical case-control trial for the comparison of docetaxel plus thiotepa versus docetaxel plus capecitabine in patients with metastatic breast cancer]. [2011.02.18]
OBJECTIVE: To evaluate the efficacy and safety of docetaxel plus thiotepa(TXT/TSPA) and docetaxel plus capecitabine(TXT/CAPE) in patients with metastatic breast cancer... CONCLUSION: Combination of docetaxel and thiotepa in the treatment of metastatic breast cancer has some curative effect and adverse reactions can be tolerated. It can be used as an economical and effective rescue plan.
[Randomized clinical case-control trial for the comparison of docetaxel plus
thiotepa versus docetaxel plus capecitabine in patients with metastatic breast
cancer]. [Article in Chinese] 
metastatic breast cancer... CONCLUSION: Combination of docetaxel and thiotepa in the treatment of metastatic
Toxicity of high-dose chemotherapy with etoposide, thiotepa and CY in treating poor-prognosis Ewing's sarcoma family tumors: the experience of the Bambino Gesu Children's Hospital. [2010.08]
We report the toxicity of high-dose chemotherapy (HDC) based on etoposide, thiotepa and CY (ETC) in children with poor-prognosis Ewing's sarcoma family tumors (ESFTs). A total of 26 patients with high-risk ESFT (metastasis or axis localization or tumor volume >200 ml or necrosis <95%) were reviewed...
The chemotherapy agent, thioTEPA, yields long-term impairment of hippocampal cell proliferation and memory deficits but not depression-related behaviors in mice. [2010.05.01]
ThioTEPA is a chemotherapeutic agent used in the treatment of cancers, and more recently has been proposed as a component of high-dose therapy for young patients with recurrent malignant brain tumors. We previously demonstrated a significant dose-dependent reduction of cell proliferation in the dentate gyrus of the hippocampus in mice immediately following a 3-day regiment of thioTEPA...
Remission re-induction chemotherapy with clofarabine, topotecan, thiotepa, and vinorelbine for patients with relapsed or refractory leukemia. [2010.05]
CONCLUSION: TVTC has significant anti-leukemic activity in both acute lymphoblastic and myeloblastic leukemia. The MTD of clofarabine is 40 mg/m(2)/day in this combination. This is the recommended dose for the phase II study in patients with refractory or relapsed leukemia, a population which has limited therapeutic options.
Clinical Trials Related to Thiotepa (Thiotepa Intracavitary)
Adjuvant High-Dose Thiotepa and Stem Cell Rescue Associated With Conventional Chemotherapy in Relapsed Osteosarcoma [Recruiting]
Approximately 150 new cases of osteosarcoma are reported each year in France, of which 15 to
20% are metastatic.
Further to the initial standard care, about 45% of the patients relapse within a median
duration of 20 months.
Result of the OS94 study results and of the investigation performed within the CRLCC,
indicate that 25 to 30 patients (children and adults) experience an osteosarcoma relapse
each year in FRANCE.
According to several studies, the 5-year overall survival rate of patients in first relapse
is 23-28%,with a median post relapse survival of 10 to 17 months. Multiple relapse cases are
also reported in the COSS study, with a median time to second relapse of 0. 8 year.
At present, there is no reference treatment for the standard care of osteosarcoma relapse in
Thiotepa is known for its antitumor effect in numerous malignant tumors. In 2007, a study
from our institution reported that about 35% of all osteosarcoma relapses are treated with a
high-dose thiotepa while the efficacy and tolerance of this therapeutic strategy have never
These results highlight the need to the evaluate the efficacy and tolerance of this
high-dose of thiotepa within a clinical trial and its inclusion in the standard care of the
osteosarcoma at relapse.
Thiotepa-based Conditioning for Allogeneic Stem-cell Transplantation (SCT) in Lymphoid Malignancies [Not yet recruiting]
The study hypotheses is that the introduction of dose escalated thiotepa, in substitution to
busulfan or melphalan, will reduce toxicity after allogeneic transplantation while improving
disease eradication in patients with lymphoid malignancies not eligible for standard
Thiotepa, Busulfan and Fludarabin for pt With Refractory/Early Relapsed Aggressive B-cell Non Hodgkin Lymphomas [Recruiting]
The purpose of this study is to evaluate progression free survival, transplant-related
morbidity (TRM) at day +100 and at +365, overall survival and incidence of acute and chronic
GVHD in refractory/early relapsed aggressive B-cell non Hodgkin lymphomas patients treated
with allogeneic Transplantation after a conditioning with Thiotepa, Busulfan and fludarabin.
Thiotepa-Clofarabine-Busulfan With Allogeneic Stem Cell Transplant for High Risk Malignancies [Active, not recruiting]
The goal of this clinical research study is to learn if thiotepa, busulfan, and clofarabine,
when given before an allogeneic (bone marrow , blood, or cord blood cells) or haploidentical
(bone marrow) stem cell transplantation can help to control cancers of the bone marrow and
lymph node system. The safety of this treatment will also be studied.
Study to Compare Busulfan-fludarabine With Thiotepa-fludarabine Regimen in Allogeneic Transplantation for Myelofibrosis [Recruiting]
This study will be performed as a prospective multicenter phase II trial for compare
busulfan-fludarabine reduced-intensity conditioning (RIC) with thiotepa-fludarabine RIC
regimen prior to allogeneic transplantation of hematopoietic cells for the treatment of
The primary endpoint for this study is to compare Progression Free Survival of two different
RIC regimens for allogeneic stem cell transplantation in myelofibrosis.
Progression Free Survival is defined as the time from the date of randomization to the date
of the first documented disease progression or relapse (according to the International
Working Group Consensus Criteria) or death due to any cause. Patients who have neither
progressed nor died at the time of study completion or who are lost to follow-up are
censored at the data of the last follow up for progression of disease for this study.
Reports of Suspected Thiotepa (Thiotepa Intracavitary) Side Effects
Respiratory Failure (9),
Acute Respiratory Distress Syndrome (7),
Immunosuppression (4), more >>
Page last updated: 2013-02-10